3,554
Participants
Start Date
August 31, 2016
Primary Completion Date
January 16, 2020
Study Completion Date
March 30, 2020
Vadadustat
Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
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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Lead Sponsor
Akebia Therapeutics
INDUSTRY