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A 24‐Week Anemia Correction Study of Daprodustat in Japanese Dialysis Patients
Author(s) -
Tsubakihara Yoshiharu,
Akizawa Tadao,
Nangaku Masaomi,
Onoue Tomohiro,
Yonekawa Taeko,
Matsushita Hideki,
Endo Yukihiro,
Cobitz Alexander
Publication year - 2020
Publication title -
therapeutic apheresis and dialysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.415
H-Index - 53
eISSN - 1744-9987
pISSN - 1744-9979
DOI - 10.1111/1744-9987.12962
Subject(s) - medicine , hemoglobin , anemia , hemodialysis , erythropoiesis , dialysis , erythropoietin , kidney disease , gastroenterology , target range , surgery , economics , macroeconomics
Daprodustat is an oral hypoxia‐inducible factor prolyl hydroxylase inhibitor developed for treating anemia of chronic kidney disease. This 24‐week, phase 3, open‐label study (NCT02829320) evaluated whether daprodustat could achieve and maintain target hemoglobin levels in Japanese hemodialysis patients with anemia not receiving an erythropoiesis‐stimulating agent. Twenty‐eight patients received daprodustat 4 mg once daily for 4 weeks, after which doses were adjusted to achieve a hemoglobin target of 10.0 to 12.0 g/dL (inclusive). Baseline mean hemoglobin was 9.10 g/dL and mean change from baseline at 4 weeks was 0.79 g/dL (95% CI, 0.53 to 1.05). Mean hemoglobin levels reached the target range by week 8 and were maintained within this range through week 24. Daprodustat 4 mg once daily increased hemoglobin over the first 4 weeks. Throughout the 24‐week study, daprodustat achieved and maintained hemoglobin within the target range and no new safety concerns were identified in hemodialysis patients not receiving erythropoiesis‐stimulating agents.