Efficacy and Safety of Daprodustat in Japanese Peritoneal Dialysis Patients.

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\u2009weeks. Subjects received daprodustat 4 mg orally once daily for 4\u2009weeks and the dose was subsequently adjusted every 4\u2009weeks. Mean baseline hemoglobin was 10.9 g/dL (95% CI 10.59, 11.12). Mean hemoglobin reached the target range (11.0 to 13.0 g/dL) at week 12 and was maintained until week 52. Mean hemoglobin during weeks 40 to 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. This article is protected by copyright. All rights reserved.