Efficacy and safety of daprodustat in Japanese peritoneal dialysis patients. Issue 6 (25th May 2021)

• Record Type: Journal Article
• Authors: Kanai, Hidetoshi; Nangaku, Masaomi; Nagai, Reiko; Okuda, Nobuhiko; Kurata, Kyo; Nagakubo, Takashi; Endo, Yukihiro; Cobitz, Alexander
• Is Part Of: Therapeutic apheresis and dialysis. Volume 25:Issue 6(2021)
• Page Start: 979
• Page End: 987
• Publication Date: 2021-05-25
• Subjects: anemia -- hypoxia -- Japanese -- peritoneal dialysis; Hemapheresis -- Periodicals; Dialysis -- Periodicals; Blood Component Removal -- Periodicals; Renal Dialysis -- Periodicals; Hémaphérèse -- Périodiques; Dialyse -- Périodiques; Sang -- Collecte et conservation -- Périodiques; 616
• DOI: 10.1111/1744-9987.13686
• Languages: English
• ISSNs: 1744-9979

Abstract

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.