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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/NCT02879305
Registration number
NCT02879305
Ethics application status
Date submitted
22/08/2016
Date registered
25/08/2016
Date last updated
3/12/2021
Titles & IDs
Public title
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
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Scientific title
A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents
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Secondary ID [1]
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2016-000541-31
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Secondary ID [2]
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200807
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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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Aspergillosis, Allergic Bronchopulmonary
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Allergies
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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 - rhEPO
Treatment: Drugs - Placebo
Treatment: Drugs - Iron therapy
Experimental: Daprodustat - Participants will receive oral daprodustat once daily.
Active Comparator: rhEPO - Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).
Treatment: Drugs: Daprodustat
Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.
Treatment: Drugs: rhEPO
The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.
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 the 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, dialysis type 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 by [*] 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 3.9 person-years for CV follow-up time period
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Primary outcome [2]
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Mean Change From Baseline in Hemoglobin (Hgb) Levels During 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 hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, missing post-Baseline hemoglobin 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.
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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, dialysis type 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 3.9 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, dialysis type 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 3.9 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, dialysis type 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 3.9 person-years for CV follow-up time period
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Secondary outcome [4]
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Mean Average Monthly On-treatment IV Iron Dose Per Participant
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Assessment method [4]
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Average monthly IV iron dose (milligrams) per participant from Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from treatment start date + 1 to the earliest of (Week 52 visit date, first blood (red blood cell [RBC] or whole blood) transfusion date, and treatment stop date + 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. This total IV iron dose was divided by (the number of days from treatment start date + 1 to the earliest of (Week 52 visit date, first blood transfusion date (RBC or whole blood), and treatment stop date +1) / 30.4375 days). This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.
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Timepoint [4]
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Day 1 to Week 52
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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, dialysis type 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 for follow-up time period.
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Timepoint [5]
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Up to 3.9 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, dialysis type 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 3.9 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, dialysis type 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 3.9 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, dialysis type 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 3.9 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 3.9 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, dialysis type 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 3.9 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) 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, dialysis type 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 3.9 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 eCRF with hospitalization duration of >=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was >=24 hours. Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. Incidence rate per 100person 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 [12]
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Up to 3.9 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, dialysis type 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 3.9 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, dialysis type 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 3.9 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, dialysis type 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 3.9 person-years for CV follow-up time period
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Secondary outcome [16]
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Change From Baseline in Post-randomization Hemoglobin Levels at Week 52
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Assessment method [16]
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Blood samples were collected from participants for hemoglobin measurements. 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 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, dialysis type, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interactions.
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Timepoint [16]
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Baseline (Pre-dose on Day 1) and Week 52
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Secondary outcome [17]
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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 [17]
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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. Hemoglobin 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 [17]
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Week 28 to Week 52
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Secondary outcome [18]
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Percentage of Time With Hemoglobin 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 [18]
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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 [18]
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Week 28 to Week 52
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Secondary outcome [19]
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Percentage of Time With Hemoglobin 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 [19]
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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 [19]
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Week 28 to Week 52
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Secondary outcome [20]
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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): Non-inferiority Analysis
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Assessment method [20]
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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 [20]
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Week 28 to end of study (3.9 person-years for follow-up time period)
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Secondary outcome [21]
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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 [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 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 [21]
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Week 28 to end of study (3.9 person-years for follow-up time period)
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Secondary outcome [22]
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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 [22]
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SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair 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 + dialysis type + 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 [22]
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Baseline (Week -4) and Week 52
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Secondary outcome [23]
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Change From Baseline in SBP, DBP, MAP at End of Treatment
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Assessment method [23]
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SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair 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. This analysis was carried out by using ANCOVA model with terms for treatment group, dialysis type, region and Baseline value. Data for post-dialysis BP measurements have been presented.
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Timepoint [23]
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0
Baseline (Week -4) and 45.1 months
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Secondary outcome [24]
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Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years
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Assessment method [24]
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BP exacerbation was defined (based on post-dialysis) 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, dialysis type 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 [24]
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Day 1 to end of study (3.9 person-years for follow-up time period)
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Secondary outcome [25]
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Number of Participants With at Least One BP Exacerbation Event During Study
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Assessment method [25]
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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 [25]
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0
Day 1 to end of study (3.9 person-years for follow-up time period)
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Secondary outcome [26]
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0
Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
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Assessment method [26]
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0
Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.
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Timepoint [26]
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Day 1 to 45.1 months
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Secondary outcome [27]
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0
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 [27]
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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 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.
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Timepoint [27]
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0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
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Secondary outcome [28]
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Change From Baseline in On-Treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
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Assessment method [28]
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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.
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Timepoint [28]
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0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
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Secondary outcome [29]
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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
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Assessment method [29]
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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, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning (Social fun), physical functioning (Phy. fun) 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 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.
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Timepoint [29]
0
0
Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
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Secondary outcome [30]
0
0
Change From Baseline in On-Treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
Query!
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). 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 [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 Physical Functioning Domain Scores 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). 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 [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 Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52
Query!
Assessment method [32]
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-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.
Query!
Timepoint [32]
0
0
Baseline (Pre-dose on Day 1) and Week 52
Query!
Secondary outcome [33]
0
0
Change From Baseline in On-Treatment EuroQol Visual Analogue Scale (EQ-VAS) at Week 52
Query!
Assessment method [33]
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 health one can imagine and 100 represents the best health one can imagine. 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) and Week 52
Query!
Secondary outcome [34]
0
0
Change From Baseline in On-Treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52
Query!
Assessment method [34]
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 worse outcome. 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!
Eligibility
Key inclusion criteria
- Age: 18 to 99 years of age (inclusive).
- Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6
weeks prior to screening and between screening and randomization.
- Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On
randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose.
Hgb >11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
- Dialysis: On dialysis >90 days prior to screening and continuing on the same mode of
dialysis from screening (Week -8) through to randomization (Day 1).
- Frequency of Dialysis: Hemodialysis (HD) >=2 times/week and peritoneal dialysis (PD)
>=5 times/week. Home hemodialysis >=2 times/week.
- Compliance with placebo [randomization (Day 1) only]: >=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 listed in the consent form
and in this protocol.
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
- 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 that would contraindicate the use of recombinant human erythropoietin
(rhEPO).
- 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 QT 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 epoetin alfa 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).
- 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 serum 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 listed in the List of Highly Effective Methods for
Avoiding Pregnancy.
- 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 rhEPO) 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
28/09/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
9/11/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2964
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Concord
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Kingswood
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Kogarah
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Liverpool
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - St Leonards
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Westmead
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Wollongong
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - Birtinya
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Herston
Query!
Recruitment hospital [10]
0
0
GSK Investigational Site - Woolloongabba
Query!
Recruitment hospital [11]
0
0
GSK Investigational Site - Adelaide
Query!
Recruitment hospital [12]
0
0
GSK Investigational Site - Clayton
Query!
Recruitment hospital [13]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment hospital [14]
0
0
GSK Investigational Site - St Albans
Query!
Recruitment hospital [15]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment hospital [16]
0
0
GSK Investigational Site - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
2750 - Kingswood
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [5]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [6]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [7]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [8]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [9]
0
0
4006 - Herston
Query!
Recruitment postcode(s) [10]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [11]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [12]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [13]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [14]
0
0
3021 - St Albans
Query!
Recruitment postcode(s) [15]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [16]
0
0
6150 - Murdoch
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
Arkansas
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
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Mississippi
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Hampshire
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Mexico
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Rhode Island
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
West Virginia
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Wisconsin
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Buenos Aires
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Córdova
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Formosa
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Mendoza
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Moron
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
San Miguel de Tucumán
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Graz
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
St. Pölten
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Wien
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Baudour
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Brugge
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Brussels
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Bruxelles
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Hasselt
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
Brazil
Query!
State/province [51]
0
0
Bahia
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Paraná
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Rio Grande Do Sul
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Santa Catarina
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
São Paulo
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
Belo Horizonte, Minas Gerais
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
Feira de Santana
Query!
Country [58]
0
0
Brazil
Query!
State/province [58]
0
0
Porto Alegre
Query!
Country [59]
0
0
Brazil
Query!
State/province [59]
0
0
Sao Paulo
Query!
Country [60]
0
0
Bulgaria
Query!
State/province [60]
0
0
Blagoevgrad
Query!
Country [61]
0
0
Bulgaria
Query!
State/province [61]
0
0
Dobrich
Query!
Country [62]
0
0
Bulgaria
Query!
State/province [62]
0
0
Gabrovo
Query!
Country [63]
0
0
Bulgaria
Query!
State/province [63]
0
0
Lom
Query!
Country [64]
0
0
Bulgaria
Query!
State/province [64]
0
0
Lovech
Query!
Country [65]
0
0
Bulgaria
Query!
State/province [65]
0
0
Montana
Query!
Country [66]
0
0
Bulgaria
Query!
State/province [66]
0
0
Pazardzhik
Query!
Country [67]
0
0
Bulgaria
Query!
State/province [67]
0
0
Plovdiv
Query!
Country [68]
0
0
Bulgaria
Query!
State/province [68]
0
0
Ruse
Query!
Country [69]
0
0
Bulgaria
Query!
State/province [69]
0
0
Smolyan
Query!
Country [70]
0
0
Bulgaria
Query!
State/province [70]
0
0
Sofia
Query!
Country [71]
0
0
Bulgaria
Query!
State/province [71]
0
0
Varna
Query!
Country [72]
0
0
Bulgaria
Query!
State/province [72]
0
0
Veliko Tarnovo
Query!
Country [73]
0
0
Canada
Query!
State/province [73]
0
0
Alberta
Query!
Country [74]
0
0
Canada
Query!
State/province [74]
0
0
Ontario
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Beroun
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Frýdek-mistek
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Ivancice
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Jilemnice
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Marianske Lazne
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Pardubice
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Praha 2
Query!
Country [82]
0
0
Czechia
Query!
State/province [82]
0
0
Praha 4
Query!
Country [83]
0
0
Czechia
Query!
State/province [83]
0
0
Sokolov
Query!
Country [84]
0
0
Denmark
Query!
State/province [84]
0
0
Aalborg
Query!
Country [85]
0
0
Denmark
Query!
State/province [85]
0
0
Holstebro
Query!
Country [86]
0
0
Denmark
Query!
State/province [86]
0
0
Kolding
Query!
Country [87]
0
0
Denmark
Query!
State/province [87]
0
0
Odense C
Query!
Country [88]
0
0
Denmark
Query!
State/province [88]
0
0
Svendborg
Query!
Country [89]
0
0
Estonia
Query!
State/province [89]
0
0
Parnu
Query!
Country [90]
0
0
Estonia
Query!
State/province [90]
0
0
Tallinn
Query!
Country [91]
0
0
Estonia
Query!
State/province [91]
0
0
Tartu
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Annonay
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Bois-Guillaume
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Bordeaux
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Boulogne Billancourt
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Caen Cedex 9
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Mulhouse
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Poitiers
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Reims
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Tours cedex 9
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Baden-Wuerttemberg
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Hessen
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Mecklenburg-Vorpommern
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Niedersachsen
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Nordrhein-Westfalen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Rheinland-Pfalz
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Schleswig-Holstein
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Dieburg
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Freiburg
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Minden
Query!
Country [111]
0
0
Greece
Query!
State/province [111]
0
0
Alexandroupolis
Query!
Country [112]
0
0
Greece
Query!
State/province [112]
0
0
Arta
Query!
Country [113]
0
0
Greece
Query!
State/province [113]
0
0
Athens
Query!
Country [114]
0
0
Greece
Query!
State/province [114]
0
0
Heraklion-Crete
Query!
Country [115]
0
0
Greece
Query!
State/province [115]
0
0
Ioannina
Query!
Country [116]
0
0
Greece
Query!
State/province [116]
0
0
Komotini
Query!
Country [117]
0
0
Greece
Query!
State/province [117]
0
0
Larissa
Query!
Country [118]
0
0
Greece
Query!
State/province [118]
0
0
Patras
Query!
Country [119]
0
0
Greece
Query!
State/province [119]
0
0
Thessaloniki
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Budapest
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Egri
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Esztergom
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Kecskemet
Query!
Country [124]
0
0
Hungary
Query!
State/province [124]
0
0
Miskolc
Query!
Country [125]
0
0
Hungary
Query!
State/province [125]
0
0
Pécs
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Szigetvar
Query!
Country [127]
0
0
India
Query!
State/province [127]
0
0
Ahmedabad
Query!
Country [128]
0
0
India
Query!
State/province [128]
0
0
Bangalore
Query!
Country [129]
0
0
India
Query!
State/province [129]
0
0
Calicut
Query!
Country [130]
0
0
India
Query!
State/province [130]
0
0
Chennai, Tamil Nadu
Query!
Country [131]
0
0
India
Query!
State/province [131]
0
0
Chennai
Query!
Country [132]
0
0
India
Query!
State/province [132]
0
0
Delhi
Query!
Country [133]
0
0
India
Query!
State/province [133]
0
0
Gurgaon
Query!
Country [134]
0
0
India
Query!
State/province [134]
0
0
Hyderabad
Query!
Country [135]
0
0
India
Query!
State/province [135]
0
0
Jaipur
Query!
Country [136]
0
0
India
Query!
State/province [136]
0
0
Mumbai
Query!
Country [137]
0
0
India
Query!
State/province [137]
0
0
Nadiad
Query!
Country [138]
0
0
India
Query!
State/province [138]
0
0
Nagpur
Query!
Country [139]
0
0
India
Query!
State/province [139]
0
0
New Delhi
Query!
Country [140]
0
0
India
Query!
State/province [140]
0
0
Pune
Query!
Country [141]
0
0
India
Query!
State/province [141]
0
0
Secunderabad
Query!
Country [142]
0
0
India
Query!
State/province [142]
0
0
Trivandrum
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Calabria
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Campania
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Emilia-Romagna
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Liguria
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Lombardia
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Piemonte
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Puglia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Sardegna
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Imola
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Mestre
Query!
Country [153]
0
0
Korea, Republic of
Query!
State/province [153]
0
0
Anyang-Si, Gyeonggi-do
Query!
Country [154]
0
0
Korea, Republic of
Query!
State/province [154]
0
0
Bucheon-si,
Query!
Country [155]
0
0
Korea, Republic of
Query!
State/province [155]
0
0
Busan
Query!
Country [156]
0
0
Korea, Republic of
Query!
State/province [156]
0
0
Daegu-si
Query!
Country [157]
0
0
Korea, Republic of
Query!
State/province [157]
0
0
Daejeon
Query!
Country [158]
0
0
Korea, Republic of
Query!
State/province [158]
0
0
Goyang-si, Gyeonggi-do
Query!
Country [159]
0
0
Korea, Republic of
Query!
State/province [159]
0
0
Goyang-si
Query!
Country [160]
0
0
Korea, Republic of
Query!
State/province [160]
0
0
Gyeonggi-do
Query!
Country [161]
0
0
Korea, Republic of
Query!
State/province [161]
0
0
Incheon
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Seoul
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Suwon
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Uijeongbu-si
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Wonju-si
Query!
Country [166]
0
0
Malaysia
Query!
State/province [166]
0
0
Batu Caves
Query!
Country [167]
0
0
Malaysia
Query!
State/province [167]
0
0
Ipoh
Query!
Country [168]
0
0
Malaysia
Query!
State/province [168]
0
0
Johor Bahru
Query!
Country [169]
0
0
Malaysia
Query!
State/province [169]
0
0
Kuala Lumpur
Query!
Country [170]
0
0
Malaysia
Query!
State/province [170]
0
0
Pahang
Query!
Country [171]
0
0
Malaysia
Query!
State/province [171]
0
0
Penang
Query!
Country [172]
0
0
Mexico
Query!
State/province [172]
0
0
Coahuila
Query!
Country [173]
0
0
Mexico
Query!
State/province [173]
0
0
Durango
Query!
Country [174]
0
0
Mexico
Query!
State/province [174]
0
0
Estado De México
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Jalisco
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Querétaro
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Yucatán
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Aguascalientes
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Chihuahua
Query!
Country [180]
0
0
Mexico
Query!
State/province [180]
0
0
México, D.F.
Query!
Country [181]
0
0
Mexico
Query!
State/province [181]
0
0
Zapopan, Jalisco
Query!
Country [182]
0
0
Netherlands
Query!
State/province [182]
0
0
Amsterdam
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Deventer
Query!
Country [184]
0
0
Netherlands
Query!
State/province [184]
0
0
Rotterdam
Query!
Country [185]
0
0
New Zealand
Query!
State/province [185]
0
0
Hamilton
Query!
Country [186]
0
0
New Zealand
Query!
State/province [186]
0
0
Hastings
Query!
Country [187]
0
0
New Zealand
Query!
State/province [187]
0
0
Otahuhu
Query!
Country [188]
0
0
Norway
Query!
State/province [188]
0
0
Oslo
Query!
Country [189]
0
0
Norway
Query!
State/province [189]
0
0
Stavanger
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Biala Podlaska
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Gdansk
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Grojec
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Kielce
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Kolobrzeg
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Kolo
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Lodz
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Olkusz
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Pruszkow
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Tomaszow Mazowiecki
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Warszawa
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Zary
Query!
Country [202]
0
0
Portugal
Query!
State/province [202]
0
0
Amadora
Query!
Country [203]
0
0
Portugal
Query!
State/province [203]
0
0
Corroios.
Query!
Country [204]
0
0
Portugal
Query!
State/province [204]
0
0
Covilhã
Query!
Country [205]
0
0
Portugal
Query!
State/province [205]
0
0
Forte Da Casa
Query!
Country [206]
0
0
Portugal
Query!
State/province [206]
0
0
Lisboa
Query!
Country [207]
0
0
Portugal
Query!
State/province [207]
0
0
Mirandela
Query!
Country [208]
0
0
Portugal
Query!
State/province [208]
0
0
Portimão
Query!
Country [209]
0
0
Portugal
Query!
State/province [209]
0
0
Vila Franca de Xira
Query!
Country [210]
0
0
Portugal
Query!
State/province [210]
0
0
Vila Real (Lordelo)
Query!
Country [211]
0
0
Romania
Query!
State/province [211]
0
0
Arad
Query!
Country [212]
0
0
Romania
Query!
State/province [212]
0
0
Bucharest
Query!
Country [213]
0
0
Romania
Query!
State/province [213]
0
0
Resita
Query!
Country [214]
0
0
Romania
Query!
State/province [214]
0
0
Targu-Jiu
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Irkutsk
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Krasnodar
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Mytischi
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Nizhniy Novgorod
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Novosibirsk
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Omsk
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Orenburg
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Penza
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
St-Petersburg
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
St. Petersburg
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Volzhsky
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Yaroslavl
Query!
Country [227]
0
0
Singapore
Query!
State/province [227]
0
0
Singapore
Query!
Country [228]
0
0
South Africa
Query!
State/province [228]
0
0
Cape Town.
Query!
Country [229]
0
0
South Africa
Query!
State/province [229]
0
0
Cape Town
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Madrid
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Alcala de Henares
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Aranda de Duero
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Badalona
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Barcelona
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Ciudad Real
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
Girona
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Guadalajara
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Manises (Valencia)
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Mollet del Valles
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Málaga
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Palma de Mallorca
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Sabadell
Query!
Country [243]
0
0
Spain
Query!
State/province [243]
0
0
Santiago de Compostela
Query!
Country [244]
0
0
Spain
Query!
State/province [244]
0
0
Sevilla
Query!
Country [245]
0
0
Spain
Query!
State/province [245]
0
0
Valladolid
Query!
Country [246]
0
0
Sweden
Query!
State/province [246]
0
0
Stockholm
Query!
Country [247]
0
0
Sweden
Query!
State/province [247]
0
0
Uppsala
Query!
Country [248]
0
0
Sweden
Query!
State/province [248]
0
0
Örebro
Query!
Country [249]
0
0
Taiwan
Query!
State/province [249]
0
0
Kaohsiung
Query!
Country [250]
0
0
Taiwan
Query!
State/province [250]
0
0
Keelung
Query!
Country [251]
0
0
Taiwan
Query!
State/province [251]
0
0
New Taipei City
Query!
Country [252]
0
0
Taiwan
Query!
State/province [252]
0
0
New Taipei
Query!
Country [253]
0
0
Taiwan
Query!
State/province [253]
0
0
Tainan
Query!
Country [254]
0
0
Taiwan
Query!
State/province [254]
0
0
Taipei
Query!
Country [255]
0
0
Taiwan
Query!
State/province [255]
0
0
Taoyuan Hsien
Query!
Country [256]
0
0
Taiwan
Query!
State/province [256]
0
0
Zhongzheng Dist., Taipei
Query!
Country [257]
0
0
Turkey
Query!
State/province [257]
0
0
Adana
Query!
Country [258]
0
0
Turkey
Query!
State/province [258]
0
0
Ankara
Query!
Country [259]
0
0
Turkey
Query!
State/province [259]
0
0
Antalya
Query!
Country [260]
0
0
Turkey
Query!
State/province [260]
0
0
Edirne
Query!
Country [261]
0
0
Turkey
Query!
State/province [261]
0
0
Eskisehir
Query!
Country [262]
0
0
Turkey
Query!
State/province [262]
0
0
Kayseri
Query!
Country [263]
0
0
Ukraine
Query!
State/province [263]
0
0
Chernihiv
Query!
Country [264]
0
0
Ukraine
Query!
State/province [264]
0
0
Chernivtsi
Query!
Country [265]
0
0
Ukraine
Query!
State/province [265]
0
0
Ivano-Frankivsk
Query!
Country [266]
0
0
Ukraine
Query!
State/province [266]
0
0
Kherson
Query!
Country [267]
0
0
Ukraine
Query!
State/province [267]
0
0
Kiev
Query!
Country [268]
0
0
Ukraine
Query!
State/province [268]
0
0
Kyiv
Query!
Country [269]
0
0
Ukraine
Query!
State/province [269]
0
0
Mykolaiv
Query!
Country [270]
0
0
Ukraine
Query!
State/province [270]
0
0
Ternopil
Query!
Country [271]
0
0
Ukraine
Query!
State/province [271]
0
0
Zaporizhzhia
Query!
Country [272]
0
0
Ukraine
Query!
State/province [272]
0
0
Zhytomyr
Query!
Country [273]
0
0
United Kingdom
Query!
State/province [273]
0
0
Hertfordshire
Query!
Country [274]
0
0
United Kingdom
Query!
State/province [274]
0
0
Lancashire
Query!
Country [275]
0
0
United Kingdom
Query!
State/province [275]
0
0
West Midlands
Query!
Country [276]
0
0
United Kingdom
Query!
State/province [276]
0
0
Birmingham
Query!
Country [277]
0
0
United Kingdom
Query!
State/province [277]
0
0
Derby
Query!
Country [278]
0
0
United Kingdom
Query!
State/province [278]
0
0
Doncaster
Query!
Country [279]
0
0
United Kingdom
Query!
State/province [279]
0
0
Dundee
Query!
Country [280]
0
0
United Kingdom
Query!
State/province [280]
0
0
Fife
Query!
Country [281]
0
0
United Kingdom
Query!
State/province [281]
0
0
Glasgow
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United Kingdom
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Hull
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United Kingdom
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London
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United Kingdom
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Oxford
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Country [285]
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United Kingdom
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Salford
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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 participants with anemia associated
with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02879305
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02879305
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