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.
References
Feb 24, 2004·Journal of the American Society of Nephrology : JASN·Albert W WuNeil R Powe
Jun 21, 2008·Current Medical Research and Opinion·Simon D RogerUNKNOWN COMFORT study group
Jan 15, 2011·Clinical and Experimental Nephrology·Tadao AkizawaUNKNOWN Chronic Kidney Disease Japan Cohort Study Group
May 29, 2012·Journal of Renal Nutrition : the Official Journal of the Council on Renal Nutrition of the National Kidney Foundation·Karen SalamonCatherine Huggins
Oct 24, 2015·Journal of the American Society of Nephrology : JASN·Louis HoldstockAlexander R Cobitz
Oct 24, 2015·Journal of the American Society of Nephrology : JASN·Colin R Lenihan, Wolfgang C Winkelmayer
Feb 2, 2016·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Richard A BrigandiUNKNOWN PHI112844 Investigators
Jul 8, 2016·PloS One·Nathan R HillF D Richard Hobbs
Dec 16, 2016·American Journal of Nephrology·Tadao AkizawaAlexander Cobitz
Dec 30, 2016·Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy·Ikuto MasakaneKosaku Nitta
Feb 13, 2019·Clinical Kidney Journal·Amy M MeadowcroftAlexander R Cobitz
Jun 22, 2019·Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy·Tadao AkizawaMai Ueno
Jul 30, 2020·Clinical Journal of the American Society of Nephrology : CJASN·Tadao AkizawaAlexander R Cobitz