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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02876835
Registration number
NCT02876835
Ethics application status
Date submitted
19/08/2016
Date registered
24/08/2016
Date last updated
2/04/2024
Titles & IDs
Public title
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
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Scientific title
A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
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Secondary ID [1]
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2016-000542-65
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Secondary ID [2]
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200808
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaemia
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Blood
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Anaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Daprodustat
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - Placebo
Treatment: Drugs - Iron Therapy
Experimental: Daprodustat - Participants will receive oral daprodustat once daily.
Active Comparator: Darbepoetin alfa - Participants will be administered darbepoetin alfa subcutaneously (SC).
Treatment: Drugs: Daprodustat
The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.
Treatment: Drugs: Darbepoetin alfa
The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.
Treatment: Drugs: Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Treatment: Drugs: Iron Therapy
Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)
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Assessment method [1]
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Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied [*] number of participants with at least 1 event) divided by [/] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [1]
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Up to 4.3 person-years for CV follow-up time period
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Primary outcome [2]
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Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52)
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Assessment method [2]
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Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.
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Timepoint [2]
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Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
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Secondary outcome [1]
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Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)
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Assessment method [1]
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Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.
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Timepoint [1]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [2]
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Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period
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Assessment method [2]
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Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.
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Timepoint [2]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [3]
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Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period
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Assessment method [3]
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Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.
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Timepoint [3]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [4]
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Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period
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Assessment method [4]
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Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for >=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [4]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [5]
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Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period
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Assessment method [5]
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Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period.
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Timepoint [5]
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Up to 4.3 person-years for vital status follow-up time period
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Secondary outcome [6]
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Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period
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Assessment method [6]
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Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [6]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [7]
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Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period
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Assessment method [7]
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Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [7]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [8]
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Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period
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Assessment method [8]
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Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [8]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [9]
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Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis)
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Assessment method [9]
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Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant.
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Timepoint [9]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [10]
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Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period
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Assessment method [10]
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Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [10]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [11]
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Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period
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Assessment method [11]
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All-cause hospitalization events were hospital admissions recorded on the hospitalization electronic case report form (eCRF) form with a hospitalization duration >=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [11]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [12]
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Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period
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Assessment method [12]
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All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization electronic case record form with hospitalization duration of >=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was >=24hours.Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, current ESA use at randomization and region as covariates.Time to the first occurrence was computed as(event date - randomization date)+1. Incidence rate per 100 person years calculated as(100*number of participants with at least 1event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [12]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [13]
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Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period
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Assessment method [13]
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Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [13]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [14]
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Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period
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Assessment method [14]
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Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [14]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [15]
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Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period
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Assessment method [15]
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Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [15]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [16]
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Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period
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Assessment method [16]
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Time to first occurrence of confirmed 40% decline in eGFR was analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [16]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [17]
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Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period
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Assessment method [17]
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Time to first occurrence of chronic dialysis was analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Chronic dialysis is defined by either initiating dialysis for >=90 days or not initiating chronic dialysis when dialysis is indicated. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [17]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [18]
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Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period
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Assessment method [18]
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Time to first occurrence of kidney transplant were analyzed using a Fine & Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
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Timepoint [18]
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Up to 4.3 person-years for CV follow-up time period
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Secondary outcome [19]
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Change From Baseline in Post-randomization Hgb Levels at Week 52
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Assessment method [19]
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Blood samples were collected from participants for Hgb measurements. Change from Baseline was defined as post-randomization value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, current ESA use, region, Baseline Hgb and Baseline Hgb by time and treatment by time interactions.
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Timepoint [19]
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Baseline (Pre-dose on Day 1) and Week 52
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Secondary outcome [20]
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Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)
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Assessment method [20]
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Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.
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Timepoint [20]
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Week 28 to Week 52
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Secondary outcome [21]
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Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis
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Assessment method [21]
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Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / [Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)].
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Timepoint [21]
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Week 28 to Week 52
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Secondary outcome [22]
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Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis
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Assessment method [22]
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Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / [Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)].
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Timepoint [22]
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Week 28 to Week 52
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Secondary outcome [23]
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Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis
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Assessment method [23]
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Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / [Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)].
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Timepoint [23]
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Week 28 to end of study (4.3 person-years for follow-up time period)
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Secondary outcome [24]
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Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis
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Assessment method [24]
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Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / [Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)].
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Timepoint [24]
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Week 28 to end of study (4.3 person-years for follow-up time period)
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Secondary outcome [25]
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Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52
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Assessment method [25]
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SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is the average (BP) in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + current ESA use at randomization + region + Baseline value + Baseline value*time + treatment group*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented.
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Timepoint [25]
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Baseline (Week -4) and Week 52
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Secondary outcome [26]
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Change From Baseline in SBP, DBP, MAP at End of Treatment
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Assessment method [26]
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SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value. Data for post-dialysis BP measurements have been presented.
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Timepoint [26]
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Baseline (Week -4) and 51.1 months
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Secondary outcome [27]
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Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years
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Assessment method [27]
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BP exacerbation event (based on post-dialysis) was defined as: SBP >= 25 millimeter of mercury (mmHg) increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the negative binomial model with treatment, current ESA use at randomization and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented.
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Timepoint [27]
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Day 1 to end of treatment (51.1 months)
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Secondary outcome [28]
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Number of Participants With at Least One BP Exacerbation Event During Study
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Assessment method [28]
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BP exacerbation was defined as: SBP >= 25 mmHg increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. Number of participants with at least one BP exacerbation event is presented.
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Timepoint [28]
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Day 1 to end of treatment (51.1 months)
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Secondary outcome [29]
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Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
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Assessment method [29]
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Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.
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Timepoint [29]
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Day 1 to 51.1 months
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Secondary outcome [30]
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Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
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Assessment method [30]
0
0
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher score represents better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [30]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Query!
Secondary outcome [31]
0
0
Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Query!
Assessment method [31]
0
0
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [31]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Query!
Secondary outcome [32]
0
0
Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
Query!
Assessment method [32]
0
0
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain (b pain), general health (GH), mental health (MH), role-emotional (RE) (role limitations caused by emotional problems), role-physical (RP) (role limitations caused by physical problems), social functioning (SF), physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline (BL) was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [32]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Query!
Secondary outcome [33]
0
0
Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Query!
Assessment method [33]
0
0
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [33]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Query!
Secondary outcome [34]
0
0
Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Query!
Assessment method [34]
0
0
The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [34]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Query!
Secondary outcome [35]
0
0
Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52
Query!
Assessment method [35]
0
0
EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.
Query!
Timepoint [35]
0
0
Baseline (Pre-dose on Day 1) and Week 52
Query!
Secondary outcome [36]
0
0
Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52
Query!
Assessment method [36]
0
0
The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [36]
0
0
Baseline (Pre-dose on Day 1) and Week 52
Query!
Secondary outcome [37]
0
0
Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52
Query!
Assessment method [37]
0
0
CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy (LE)/Weak scale consisting of 10 items; 2.Chest Pain (CP)/Shortness of Breath (SOB) scale consisting of 4 items; and 3.Cognitive (Cog) scale consisting of 3 items. The 4 CKD-AQ single items are: shortness of breath, no activity; severity-short breath (S-SB), resting; difficulty standing (diff. std.)for long time (LT) and difficulty sleeping (diff sleep). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [37]
0
0
Baseline (Day 1) and Weeks 8, 12, 28, 52
Query!
Secondary outcome [38]
0
0
Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52
Query!
Assessment method [38]
0
0
The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated more disease severity. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [38]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Query!
Secondary outcome [39]
0
0
Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52
Query!
Assessment method [39]
0
0
Blood samples were collected to analyze estimated glomerular filtration rate. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Query!
Timepoint [39]
0
0
Baseline (Pre-dose on Day 1) and Week 52
Query!
Eligibility
Key inclusion criteria
- Age: 18 to 99 years of age (inclusive)
- CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5
defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
- Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use
within the 6 weeks prior to screening and no ESA use between screening and
randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks
prior to screening and continuing between screening and randomization.
- For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to
10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8
should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
- >=80% and <=120% compliance with placebo during run-in period.
- Informed consent (screening only): capable of giving signed informed consent which
includes compliance with the requirements and restrictions.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis
within 90 days after study start (Day 1).
- Kidney transplant: Planned living-related or living-unrelated kidney transplant within
52 weeks after study start (Day 1).
- Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at
screening.
- Transferrin saturation (TSAT) (screening only): <=20%.
- Aplasias: History of bone marrow aplasia or pure red cell aplasia.
- Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell
disease or myelodysplastic syndrome.
- Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or
esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to
screening through to randomization (Day 1).
- MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization
(Day 1).
- Stroke or transient ischemic attack: <=4 weeks prior to screening through to
randomization (Day 1).
- Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association
(NYHA) functional classification system.
- Current uncontrolled hypertension: Current uncontrolled hypertension as determined by
the investigator.
- Bazett's corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB
>530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for
Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
- Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening.
- Bilirubin: >1.5xULN at screening.
- Current unstable liver or biliary disease per investigator assessment, generally
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia,
esophageal or gastric varices, persistent jaundice, or cirrhosis.
- Malignancy: History of malignancy within the 2 years prior to screening through to
randomization (Day 1) or currently receiving treatment for cancer, or complex kidney
cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the
exception of localized squamous cell or basal cell carcinoma of the skin that has been
definitively treated >=4 weeks prior to screening.
- Severe allergic reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product, or darbepoetin alfa.
- Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g.,
gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
- Other study participation: Use of other investigational agent or device prior to
screening through to randomization (Day 1). At screening, this exclusion applies to
use of the investigational agent within 30 days or within five half lives (whichever
is longer).
- Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment
duration of >30 days.
- Females only: Subject is pregnant [as confirmed by a positive urine human chorionic
gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is
breastfeeding, or subject is of reproductive potential and does not agree to follow
one of the contraceptive options.
- Other Conditions: Any other condition, clinical or laboratory abnormality, or
examination finding that the investigator considers would put the subject at
unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin
alfa) or prevent understanding of the aims or investigational procedures or possible
consequences of the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/09/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/04/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
3872
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Garran
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Concord
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Gosford
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Kingswood
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Kogarah
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Randwick
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - St Leonards
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - Wollongong
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Nambour
Query!
Recruitment hospital [10]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment hospital [11]
0
0
GSK Investigational Site - Reservoir
Query!
Recruitment hospital [12]
0
0
GSK Investigational Site - St Albans
Query!
Recruitment hospital [13]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment hospital [14]
0
0
GSK Investigational Site - Liverpool
Query!
Recruitment postcode(s) [1]
0
0
2606 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [3]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [4]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [5]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [6]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [7]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [8]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [9]
0
0
4560 - Nambour
Query!
Recruitment postcode(s) [10]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
3073 - Reservoir
Query!
Recruitment postcode(s) [12]
0
0
3021 - St Albans
Query!
Recruitment postcode(s) [13]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [14]
0
0
2107 - Liverpool
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Louisiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maryland
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Massachusetts
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Michigan
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Minnesota
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Mississippi
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Missouri
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nebraska
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nevada
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New York
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
North Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Dakota
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Ohio
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Oklahoma
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Oregon
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Pennsylvania
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
South Carolina
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Tennessee
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Texas
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
West Virginia
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Buenos Aires
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Córdova
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Corrientes
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Formosa
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
La Plata
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Mendoza
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Moron
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
San Miguel de Tucumán
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Aalst
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Baudour
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Brugge
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Brussels
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Ieper
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Leuven
Query!
Country [49]
0
0
Belgium
Query!
State/province [49]
0
0
Liège
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Roeselare
Query!
Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Ronse
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Sint-Niklaas
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Bahia
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Paraná
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Rio Grande Do Sul
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
São Paulo
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
Belo Horizonte
Query!
Country [58]
0
0
Brazil
Query!
State/province [58]
0
0
Brasilia
Query!
Country [59]
0
0
Brazil
Query!
State/province [59]
0
0
Feira de Santana
Query!
Country [60]
0
0
Brazil
Query!
State/province [60]
0
0
Joinville
Query!
Country [61]
0
0
Brazil
Query!
State/province [61]
0
0
Juiz De Fora
Query!
Country [62]
0
0
Brazil
Query!
State/province [62]
0
0
Sao Paulo
Query!
Country [63]
0
0
Bulgaria
Query!
State/province [63]
0
0
Blagoevgrad
Query!
Country [64]
0
0
Bulgaria
Query!
State/province [64]
0
0
Burgas
Query!
Country [65]
0
0
Bulgaria
Query!
State/province [65]
0
0
Dobrich
Query!
Country [66]
0
0
Bulgaria
Query!
State/province [66]
0
0
Gabrovo
Query!
Country [67]
0
0
Bulgaria
Query!
State/province [67]
0
0
Lom
Query!
Country [68]
0
0
Bulgaria
Query!
State/province [68]
0
0
Pazardzhik
Query!
Country [69]
0
0
Bulgaria
Query!
State/province [69]
0
0
Plovdiv
Query!
Country [70]
0
0
Bulgaria
Query!
State/province [70]
0
0
Sliven
Query!
Country [71]
0
0
Bulgaria
Query!
State/province [71]
0
0
Smolyan
Query!
Country [72]
0
0
Bulgaria
Query!
State/province [72]
0
0
Sofia
Query!
Country [73]
0
0
Bulgaria
Query!
State/province [73]
0
0
Stara Zagora
Query!
Country [74]
0
0
Bulgaria
Query!
State/province [74]
0
0
Varna
Query!
Country [75]
0
0
Bulgaria
Query!
State/province [75]
0
0
Veliko Tarnovo
Query!
Country [76]
0
0
Canada
Query!
State/province [76]
0
0
Alberta
Query!
Country [77]
0
0
Canada
Query!
State/province [77]
0
0
Nova Scotia
Query!
Country [78]
0
0
Canada
Query!
State/province [78]
0
0
Ontario
Query!
Country [79]
0
0
Canada
Query!
State/province [79]
0
0
Quebec
Query!
Country [80]
0
0
Colombia
Query!
State/province [80]
0
0
Barranquilla
Query!
Country [81]
0
0
Colombia
Query!
State/province [81]
0
0
Bogotá
Query!
Country [82]
0
0
Colombia
Query!
State/province [82]
0
0
Cali
Query!
Country [83]
0
0
Colombia
Query!
State/province [83]
0
0
Floridablanca
Query!
Country [84]
0
0
Colombia
Query!
State/province [84]
0
0
Medellin
Query!
Country [85]
0
0
Czechia
Query!
State/province [85]
0
0
Beroun
Query!
Country [86]
0
0
Czechia
Query!
State/province [86]
0
0
Cesky Krumlov
Query!
Country [87]
0
0
Czechia
Query!
State/province [87]
0
0
Ivancice
Query!
Country [88]
0
0
Czechia
Query!
State/province [88]
0
0
Jilemnice
Query!
Country [89]
0
0
Czechia
Query!
State/province [89]
0
0
Marianske Lazne
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Novy Jicin
Query!
Country [91]
0
0
Czechia
Query!
State/province [91]
0
0
Pardubice
Query!
Country [92]
0
0
Czechia
Query!
State/province [92]
0
0
Praha 2
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Praha 4
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Sokolov
Query!
Country [95]
0
0
Denmark
Query!
State/province [95]
0
0
Aalborg
Query!
Country [96]
0
0
Denmark
Query!
State/province [96]
0
0
Holstebro
Query!
Country [97]
0
0
Denmark
Query!
State/province [97]
0
0
Kolding
Query!
Country [98]
0
0
Denmark
Query!
State/province [98]
0
0
Odense C
Query!
Country [99]
0
0
Estonia
Query!
State/province [99]
0
0
Jämejala Village
Query!
Country [100]
0
0
Estonia
Query!
State/province [100]
0
0
Tallinn
Query!
Country [101]
0
0
Estonia
Query!
State/province [101]
0
0
Tartu
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Annonay
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Boulogne Billancourt
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Caen Cedex 9
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Clermont-Ferrand
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Lyon
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Montpellier
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Mulhouse
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Poitiers
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Saint-Ouen
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Baden-Wuerttemberg
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Bayern
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Niedersachsen
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Nordrhein-Westfalen
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Rheinland-Pfalz
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Sachsen
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Koeln
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Wiesbaden
Query!
Country [119]
0
0
Greece
Query!
State/province [119]
0
0
Alexandroupolis
Query!
Country [120]
0
0
Greece
Query!
State/province [120]
0
0
Arta
Query!
Country [121]
0
0
Greece
Query!
State/province [121]
0
0
Athens
Query!
Country [122]
0
0
Greece
Query!
State/province [122]
0
0
Efkarpia
Query!
Country [123]
0
0
Greece
Query!
State/province [123]
0
0
Heraklion-Crete
Query!
Country [124]
0
0
Greece
Query!
State/province [124]
0
0
Ioannina
Query!
Country [125]
0
0
Greece
Query!
State/province [125]
0
0
Komotini
Query!
Country [126]
0
0
Greece
Query!
State/province [126]
0
0
Larissa
Query!
Country [127]
0
0
Greece
Query!
State/province [127]
0
0
Melissia
Query!
Country [128]
0
0
Greece
Query!
State/province [128]
0
0
Patras
Query!
Country [129]
0
0
Greece
Query!
State/province [129]
0
0
Thessaloniki
Query!
Country [130]
0
0
Hong Kong
Query!
State/province [130]
0
0
Hong Kong
Query!
Country [131]
0
0
Hong Kong
Query!
State/province [131]
0
0
Lai Chi kok
Query!
Country [132]
0
0
Hong Kong
Query!
State/province [132]
0
0
New Territories
Query!
Country [133]
0
0
Hong Kong
Query!
State/province [133]
0
0
Tsuen Wan
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Baja
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Balatonfured
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Esztergom
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Kecskemét
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Miskolc
Query!
Country [139]
0
0
Hungary
Query!
State/province [139]
0
0
Pecs
Query!
Country [140]
0
0
Hungary
Query!
State/province [140]
0
0
Salgótarján
Query!
Country [141]
0
0
Hungary
Query!
State/province [141]
0
0
Szigetvar
Query!
Country [142]
0
0
India
Query!
State/province [142]
0
0
Ahmedabad
Query!
Country [143]
0
0
India
Query!
State/province [143]
0
0
Bangalore
Query!
Country [144]
0
0
India
Query!
State/province [144]
0
0
Calicut
Query!
Country [145]
0
0
India
Query!
State/province [145]
0
0
Chandigarh
Query!
Country [146]
0
0
India
Query!
State/province [146]
0
0
Chennai, Tamil Nadu
Query!
Country [147]
0
0
India
Query!
State/province [147]
0
0
Chennai
Query!
Country [148]
0
0
India
Query!
State/province [148]
0
0
Delhi
Query!
Country [149]
0
0
India
Query!
State/province [149]
0
0
Ghaziabad
Query!
Country [150]
0
0
India
Query!
State/province [150]
0
0
Gurgaon
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Hyderabad
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Jaipur
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
Lucknow
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Manipal
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
Mumbai
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
Nadiad
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
Nagpur
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
New Delhi
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Pune
Query!
Country [160]
0
0
India
Query!
State/province [160]
0
0
Secunderabad
Query!
Country [161]
0
0
India
Query!
State/province [161]
0
0
Trivandrum
Query!
Country [162]
0
0
Israel
Query!
State/province [162]
0
0
Ashkelon
Query!
Country [163]
0
0
Israel
Query!
State/province [163]
0
0
Hadera
Query!
Country [164]
0
0
Israel
Query!
State/province [164]
0
0
Haifa
Query!
Country [165]
0
0
Israel
Query!
State/province [165]
0
0
Kfar Saba
Query!
Country [166]
0
0
Israel
Query!
State/province [166]
0
0
Nahariya
Query!
Country [167]
0
0
Israel
Query!
State/province [167]
0
0
Nazareth
Query!
Country [168]
0
0
Israel
Query!
State/province [168]
0
0
Poriya
Query!
Country [169]
0
0
Israel
Query!
State/province [169]
0
0
Zerifin
Query!
Country [170]
0
0
Italy
Query!
State/province [170]
0
0
Calabria
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Campania
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Emilia-Romagna
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Liguria
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Lombardia
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Piemonte
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Puglia
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Sardegna
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Imola
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Mestre
Query!
Country [180]
0
0
Korea, Republic of
Query!
State/province [180]
0
0
Anyang-Si, Gyeonggi-do
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Bucheon
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Busan
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Daegu
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Daejeon
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Goyang-si
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Ilsanseo-gu, Goyang-si,
Query!
Country [187]
0
0
Korea, Republic of
Query!
State/province [187]
0
0
Incheon
Query!
Country [188]
0
0
Korea, Republic of
Query!
State/province [188]
0
0
Jeonju-si
Query!
Country [189]
0
0
Korea, Republic of
Query!
State/province [189]
0
0
Seongnam
Query!
Country [190]
0
0
Korea, Republic of
Query!
State/province [190]
0
0
Seoul
Query!
Country [191]
0
0
Korea, Republic of
Query!
State/province [191]
0
0
Suwon
Query!
Country [192]
0
0
Korea, Republic of
Query!
State/province [192]
0
0
Uijeongbu-si
Query!
Country [193]
0
0
Korea, Republic of
Query!
State/province [193]
0
0
Wonju-si
Query!
Country [194]
0
0
Malaysia
Query!
State/province [194]
0
0
Alor Setar
Query!
Country [195]
0
0
Malaysia
Query!
State/province [195]
0
0
Ipoh
Query!
Country [196]
0
0
Malaysia
Query!
State/province [196]
0
0
Kuala Lumpur
Query!
Country [197]
0
0
Malaysia
Query!
State/province [197]
0
0
Kuantan
Query!
Country [198]
0
0
Malaysia
Query!
State/province [198]
0
0
Lumut
Query!
Country [199]
0
0
Malaysia
Query!
State/province [199]
0
0
Pahang
Query!
Country [200]
0
0
Malaysia
Query!
State/province [200]
0
0
Penang
Query!
Country [201]
0
0
Mexico
Query!
State/province [201]
0
0
Coahuila
Query!
Country [202]
0
0
Mexico
Query!
State/province [202]
0
0
Durango
Query!
Country [203]
0
0
Mexico
Query!
State/province [203]
0
0
Estado De México
Query!
Country [204]
0
0
Mexico
Query!
State/province [204]
0
0
Guanajuato
Query!
Country [205]
0
0
Mexico
Query!
State/province [205]
0
0
Jalisco
Query!
Country [206]
0
0
Mexico
Query!
State/province [206]
0
0
Morelos
Query!
Country [207]
0
0
Mexico
Query!
State/province [207]
0
0
Nuevo León
Query!
Country [208]
0
0
Mexico
Query!
State/province [208]
0
0
Querétaro
Query!
Country [209]
0
0
Mexico
Query!
State/province [209]
0
0
Sinaloa
Query!
Country [210]
0
0
Mexico
Query!
State/province [210]
0
0
Yucatán
Query!
Country [211]
0
0
Mexico
Query!
State/province [211]
0
0
Aguascalientes
Query!
Country [212]
0
0
Mexico
Query!
State/province [212]
0
0
Chihuahua
Query!
Country [213]
0
0
Mexico
Query!
State/province [213]
0
0
Ciudad De México
Query!
Country [214]
0
0
Mexico
Query!
State/province [214]
0
0
Culiacan
Query!
Country [215]
0
0
Mexico
Query!
State/province [215]
0
0
Tlalnepantla De Baz
Query!
Country [216]
0
0
Mexico
Query!
State/province [216]
0
0
Veracruz
Query!
Country [217]
0
0
Mexico
Query!
State/province [217]
0
0
Zapopan, Jalisco
Query!
Country [218]
0
0
Netherlands
Query!
State/province [218]
0
0
Amsterdam
Query!
Country [219]
0
0
Netherlands
Query!
State/province [219]
0
0
Deventer
Query!
Country [220]
0
0
Netherlands
Query!
State/province [220]
0
0
Rotterdam
Query!
Country [221]
0
0
New Zealand
Query!
State/province [221]
0
0
Dunedin
Query!
Country [222]
0
0
New Zealand
Query!
State/province [222]
0
0
Hamilton
Query!
Country [223]
0
0
New Zealand
Query!
State/province [223]
0
0
Hastings
Query!
Country [224]
0
0
New Zealand
Query!
State/province [224]
0
0
Otahuhu
Query!
Country [225]
0
0
New Zealand
Query!
State/province [225]
0
0
Takapuna, Auckland
Query!
Country [226]
0
0
Philippines
Query!
State/province [226]
0
0
Baguio City, Benguet
Query!
Country [227]
0
0
Philippines
Query!
State/province [227]
0
0
Cebu City
Query!
Country [228]
0
0
Philippines
Query!
State/province [228]
0
0
Dasmarinas
Query!
Country [229]
0
0
Philippines
Query!
State/province [229]
0
0
Iloilo City
Query!
Country [230]
0
0
Philippines
Query!
State/province [230]
0
0
Manila
Query!
Country [231]
0
0
Philippines
Query!
State/province [231]
0
0
Pasig
Query!
Country [232]
0
0
Philippines
Query!
State/province [232]
0
0
Quezon City
Query!
Country [233]
0
0
Philippines
Query!
State/province [233]
0
0
San Juan
Query!
Country [234]
0
0
Philippines
Query!
State/province [234]
0
0
Sto Tomas
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Bialystok
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Brzeg
Query!
Country [237]
0
0
Poland
Query!
State/province [237]
0
0
Gdansk
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Katowice
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Kielce
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Kolobrzeg
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Lodz
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Radom
Query!
Country [243]
0
0
Poland
Query!
State/province [243]
0
0
Szczecin
Query!
Country [244]
0
0
Poland
Query!
State/province [244]
0
0
Zyrardow
Query!
Country [245]
0
0
Portugal
Query!
State/province [245]
0
0
Amadora
Query!
Country [246]
0
0
Portugal
Query!
State/province [246]
0
0
Aveiro
Query!
Country [247]
0
0
Portugal
Query!
State/province [247]
0
0
Covilhã
Query!
Country [248]
0
0
Portugal
Query!
State/province [248]
0
0
Lisboa
Query!
Country [249]
0
0
Portugal
Query!
State/province [249]
0
0
Torres Novas
Query!
Country [250]
0
0
Romania
Query!
State/province [250]
0
0
Bucharest
Query!
Country [251]
0
0
Romania
Query!
State/province [251]
0
0
Bucuresti
Query!
Country [252]
0
0
Romania
Query!
State/province [252]
0
0
Constanta
Query!
Country [253]
0
0
Romania
Query!
State/province [253]
0
0
Oradea
Query!
Country [254]
0
0
Romania
Query!
State/province [254]
0
0
Timisoara
Query!
Country [255]
0
0
Russian Federation
Query!
State/province [255]
0
0
Irkutsk
Query!
Country [256]
0
0
Russian Federation
Query!
State/province [256]
0
0
Kemerovo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
The purpose of this multi-center event-driven study in non-dialysis (ND) participants with
anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of
daprodustat compared to darbepoetin alfa.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02876835
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Trial related presentations / publications
Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196
Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.
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Public notes
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02876835
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