Efficacy and safety of daprodustat compared with darbepoetin alfa in Japanese hemodialysis patients with anemia: A randomized, double-blind, phase 3 trial
Clinical Journal of the American Society of Nephrology Aug 03, 2020
Akizawa T, Nangaku M, Yonekawa T, et al. - This randomized, phase 3, double-blind, active-control study was undertaken to assess the efficacy (noninferiority) as well as the safety of daprodustat vs standard therapy (darbepoetin alfa) in Japanese patients undergoing hemodialysis with anemia of CKD. From current erythropoiesis-stimulating agents (ESAs), patients were switched to daprodustat 4 mg once daily or darbepoetin alfa 10–60 μg once weekly (based on the prestudy ESA dose). As per a protocol-specified algorithm, dose was adjusted every 4 weeks for daprodustat or every 2 weeks for darbepoetin alfa. Mean hemoglobin during weeks 40–52 in the intent-to-treat population was the primary endpoint. Findings revealed the noninferiority of oral daprodustat to darbepoetin alfa, based on mean hemoglobin over weeks 40–52 in Japanese patients undergoing hemodialysis switched from ESAs.
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