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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/NCT02680574
Registration number
NCT02680574
Ethics application status
Date submitted
9/02/2016
Date registered
11/02/2016
Date last updated
27/06/2022
Titles & IDs
Public title
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
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Scientific title
Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
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Secondary ID [1]
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2015-004774-14
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Secondary ID [2]
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AKB-6548-CI-0015
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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:
Anemia
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Non-Dialysis-Dependent Chronic Kidney Disease
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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 - Vadadustat
Treatment: Drugs - Darbepoetin alfa
Experimental: Vadadustat -
Active Comparator: Darbepoetin alfa -
Treatment: Drugs: Vadadustat
Oral dose administered once daily for =36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Treatment: Drugs: Darbepoetin alfa
Subcutaneous or intravenous dose administered for =36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
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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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Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
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Assessment method [1]
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The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus =10.0 g/dL), geographic region (United States [US] versus European Union [EU] versus Rest of World [ROW]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 [no CHF] or I versus II or III) as covariates.
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Timepoint [1]
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Baseline; Weeks 24 to 36
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Primary outcome [2]
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Median Time to First Major Adverse Cardiovascular Event (MACE)
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Assessment method [2]
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MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0015 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
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Timepoint [2]
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Up to Week 208
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Secondary outcome [1]
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Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
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Assessment method [1]
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The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus =10.0 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 [no CHF] or I versus II or III) as covariates.
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Timepoint [1]
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Baseline; Weeks 40 to 52
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Secondary outcome [2]
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Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
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Assessment method [2]
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MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment. EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0015 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
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Timepoint [2]
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Up to Week 208
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Secondary outcome [3]
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Median Time to First Cardiovascular MACE
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Assessment method [3]
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MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e, only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0015 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
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Timepoint [3]
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Up to Week 208
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Secondary outcome [4]
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Median Time to First Cardiovascular Death
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Assessment method [4]
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Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0015 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
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Timepoint [4]
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Up to Week 208
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Secondary outcome [5]
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Median Time to First All-cause Mortality
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Assessment method [5]
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Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0015 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
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Timepoint [5]
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Up to Week 208
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Eligibility
Key inclusion criteria
- =18 years of age
- Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate
=60 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at Screening and
not expected to start dialysis within 6 months of Screening
- Currently maintained on erythropoiesis-stimulating agents therapy, with a dose
received within 6 weeks prior to or during Screening
- Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive)
in the United States (US) and between 9.0 and 12.0 g/dL (inclusive) outside of the US
- Serum ferritin =100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT)
=20% during Screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Anemia due to a cause other than CKD or participant with active bleeding or recent
blood loss
- Red blood cell transfusion within 8 weeks prior to randomization
- Uncontrolled hypertension
- Severe heart failure at Screening (New York Heart Association Class IV)
- Acute coronary syndrome (hospitalization for unstable angina or myocardial
infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or
peripheral artery disease (aortic or lower extremity), surgical or percutaneous
valvular replacement or repair, sustained ventricular tachycardia, hospitalization for
heart failure, or stroke within 12 weeks prior to or during Screening
- Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2020
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Sample size
Target
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Accrual to date
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Final
1725
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2170 - Liverpool
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2145 - Westmead
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4870 - Cairns
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9726 - Gold Coast
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5000 - Adelaide
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7250 - Launceston
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3165 - Bentleigh East
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3128 - Box Hill
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3065 - Fitzroy
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6009 - Nedlands
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6000 - Perth
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Recruitment outside Australia
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Germany
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Mecklenburg Vorpommern
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Germany
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Nordrhein Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Baja
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Budapest
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Debrecen
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Esztergom
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Hungary
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Hodmezovasarhely
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Hungary
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Kalocsa
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Hungary
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Hungary
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Hungary
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Kistarcsa
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Hungary
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Pecs
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Hungary
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Szeged
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Hungary
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Szigetvar
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Israel
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Ramat Gan
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Israel
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Rishon Lezion
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Italy
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Caserta
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Italy
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Foggia
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Italy
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Bari
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Italy
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Lecco
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Italy
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Milano
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Italy
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Italy
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Italy
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Pavia
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Italy
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Italy
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Busan
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Daegu
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Seoul
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Distrito Federal
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Mexico
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Mexico
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Mexico
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Nowa Sol
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Caguas
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Pushkin
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Russian Federation
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Russian Federation
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Serbia
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Belgrade
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Lazarevac
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Serbia
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Nis
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Serbia
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Zajecar
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Trstena
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Gauteng
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South Africa
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Alicante
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Madrid
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Valencia
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Istanbul
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Kocaeli
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Mykolaiv
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Ukraine
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Odesa
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Zaporizhzhia
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United Kingdom
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Devon
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United Kingdom
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Greater London
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Akebia Therapeutics
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Address
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Country
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Ethics approval
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Summary
Brief summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance
treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease
(NDD-CKD)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02680574
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Public notes
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Contacts
Principal investigator
Name
0
0
Chief Medical Officer
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Address
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Akebia Therapeutics Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02680574
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