Three Times Weekly Dosing of Daprodustat versus Conventional Epoetin for Treatment of Anemia in Hemodialysis Patients

Autor: Daniel W. Coyne, Ajay K. Singh, Renato D. Lopes, Christine K. Bailey, Tara L. DiMino, Chun Huang, Jeffrey Connaire, Anjay Rastogi, Sung-Gyun Kim, Marcelo Orias, Sapna Shah, Vickas Patel, Alexander R. Cobitz, Christoph Wanner
Rok vydání: 2022
Předmět:
Zdroj: Clinical Journal of the American Society of Nephrology. 17:1325-1336
ISSN: 1555-905X
1555-9041
DOI: 10.2215/cjn.00550122
Popis: Daprodustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being investigated for the treatment of anemia of CKD. In this noninferiority trial, we compared daprodustat administered three times weekly with epoetin alfa (epoetin) in patients on prevalent hemodialysis switching from a prior erythropoiesis-stimulating agent (ESA).Patients on hemodialysis with a baseline hemoglobin of 8-11.5 g/dl receiving an ESA were randomized 2:1 to daprodustat three times weekly (Daprodustat three times weekly was noninferior to epoetin for mean change in hemoglobin (model-adjusted mean treatment difference [daprodustat-epoetin], -0.05; 95% confidence interval, -0.21 to 0.10). During the evaluation period, mean (SD) hemoglobin values were 10.45 (0.55) and 10.51 (0.85) g/dl for daprodustat and epoetin groups, respectively. Responders (defined as mean hemoglobin during the evaluation period in the analysis range of 10 to 11.5 g/dl) were 80% in the daprodustat group versus 64% in the epoetin group. Proportionately fewer participants in the daprodustat group versus the epoetin group had hemoglobin values either below 10 g/dl or above 11.5 g/dl during the evaluation period. Mean monthly intravenous iron use was not significantly lower with daprodustat versus epoetin. The effect on BP was similar between groups. The percentage of treatment-emergent adverse events was similar between daprodustat (75%) and epoetin (79%).Daprodustat was noninferior to epoetin in hemoglobin response and was generally well tolerated.Anemia Studies in Chronic Kidney Disease: Erythropoiesis
Databáze: OpenAIRE
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