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

Ther Apher Dial. 2020 Apr;24(2):108-114. doi: 10.1111/1744-9987.12962. Epub 2019 Aug 13.

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 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.

Keywords: Anemia; Chronic kidney disease; Daprodustat; Dialysis; Japanese.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Aged
  • Anemia / drug therapy*
  • Anemia / etiology
  • Barbiturates / adverse effects
  • Barbiturates / therapeutic use*
  • Female
  • Glycine / adverse effects
  • Glycine / analogs & derivatives*
  • Glycine / therapeutic use
  • Hemoglobins / analysis
  • Humans
  • Hypoxia-Inducible Factor-Proline Dioxygenases / antagonists & inhibitors
  • Japan
  • Male
  • Middle Aged
  • Renal Dialysis*
  • Renal Insufficiency, Chronic / complications
  • Renal Insufficiency, Chronic / therapy*
  • Treatment Outcome

Substances

  • Barbiturates
  • GSK1278863
  • Hemoglobins
  • Hypoxia-Inducible Factor-Proline Dioxygenases
  • Glycine