Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan

Ther Apher Dial. 2021 Oct;25(5):642-653. doi: 10.1111/1744-9987.13611. Epub 2020 Dec 29.

Abstract

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in patients with chronic kidney disease (CKD). This phase 3, open-label, 24-week single-arm study evaluated the efficacy and safety of vadadustat in 42 Japanese CKD patients with anemia undergoing peritoneal dialysis. Patients received oral vadadustat for 24 weeks, initiated at 300 mg/day and doses were adjusted to achieve the target hemoglobin (Hb) range of 11.0-13.0 g/dL. Least squares mean of average Hb at weeks 20 and 24 was 11.35 g/dL, which was within the target range. The most frequent adverse events were catheter site infections (23.8%), which were not related to vadadustat treatment. Vadadustat was generally well tolerated and effective in controlling Hb levels within the target range, indicating the usefulness of vadadustat for treating anemia in Japanese CKD patients undergoing peritoneal dialysis.

Keywords: anemia; chronic kidney disease; hypoxia-inducible factor prolyl hydroxylase inhibitor; peritoneal dialysis; vadadustat.

Publication types

  • Clinical Trial, Phase III

MeSH terms

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

Substances

  • Picolinic Acids
  • vadadustat
  • Glycine