期刊
THERAPEUTIC APHERESIS AND DIALYSIS
卷 25, 期 6, 页码 979-987出版社
WILEY
DOI: 10.1111/1744-9987.13686
关键词
anemia; hypoxia; Japanese; peritoneal dialysis
资金
- GlaxoSmithKline (GSK)
- GSK
This study demonstrated the efficacy and safety of daprodustat in Japanese peritoneal dialysis patients with anemia, with mean hemoglobin levels reaching and remaining within the target range over 52 weeks. Adverse events were generally well tolerated, with the most common being nasopharyngitis, catheter-site infection, peritonitis, diarrhea, and nausea. No deaths were reported.
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.
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