Efficacy and safety of daprodustat in Japanese peritoneal dialysis patients

Ther Apher Dial. 2021 Dec;25(6):979-987. doi: 10.1111/1744-9987.13686. Epub 2021 May 25.

Abstract

Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anemia of chronic kidney disease. This phase 3 study evaluated the efficacy and safety of daprodustat in an uncontrolled cohort of 56 Japanese peritoneal dialysis patients with anemia over 52 weeks. Subjects received daprodustat 4 mg orally once daily for 4 weeks and the dose was subsequently adjusted every 4 weeks. Mean baseline hemoglobin was 10.9 g/dL (95% CI 10.59, 11.12). Mean hemoglobin reached the target range (11.0-13.0 g/dL) at week 12 and was maintained until week 52. Mean hemoglobin during weeks 40-52 was 12.1 g/dL (95% CI 12.0, 12.2). The most frequent adverse events included nasopharyngitis (29%), catheter-site infection (18%), peritonitis (16%), diarrhea (14%), and nausea (11%). No deaths were reported. Once-daily oral daprodustat treatment was generally well tolerated and mean hemoglobin was achieved and maintained within the target range in Japanese peritoneal dialysis participants.

Keywords: Japanese; anemia; hypoxia; peritoneal dialysis.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Anemia / complications*
  • Anemia / drug therapy*
  • Barbiturates / adverse effects
  • Barbiturates / therapeutic use*
  • Cohort Studies
  • Female
  • Glycine / adverse effects
  • Glycine / analogs & derivatives*
  • Glycine / therapeutic use
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Peritoneal Dialysis / methods*
  • Renal Insufficiency, Chronic / complications*
  • Renal Insufficiency, Chronic / therapy*
  • Treatment Outcome

Substances

  • Barbiturates
  • GSK1278863
  • Glycine