A 24‐Week Anemia Correction Study of Daprodustat in Japanese Dialysis Patients

Abstract

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\u2009mg once daily for 4\u2009weeks, after which doses were adjusted to achieve a hemoglobin target of 10.0 to 12.0\u2009g/dL (inclusive). Baseline mean hemoglobin was 9.10\u2009g/dL and mean change from baseline at 4\u2009weeks was 0.79\u2009g/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\u2009mg once daily increased hemoglobin over the first 4\u2009weeks. 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.