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Phase 3 randomized study comparing vadadustat with darbepoetin alfa for anemia in Japanese patients with nondialysis-dependent CKD

Journal of the American Society of Nephrology Apr 28, 2021

Nangaku M, Kondo K, Kokado Y, et al. - Researchers tested efficacy as well as safety of vadadustat (an oral hypoxia-inducible factor prolyl hydroxylase inhibitor) vs that of darbepoetin alfa in Japanese adults (n = 304) with anemia in nondialysis-dependent CKD (NDD-CKD) (including erythropoiesis-stimulating agent users and nonusers) in this phase 3, open-label, active-controlled noninferiority trial. Participants were randomly assigned to oral vadadustat or subcutaneous darbepoetin alfa for 52 weeks. Findings demonstrated the noninferiority of vadadustat to darbepoetin alfa, as well as its effectiveness up to week 52 in terms of average hemoglobin in Japanese patients with NDD-CKD. A general good tolerability of vadadustat was also evident. It was indicated that vadadustat may serve as a potential treatment choice for anemia in these patients.

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