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Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis
Journal
New England Journal of Medicine
ISSN
0028-4793
1533-4406
Date Issued
2021
Author(s)
Singh, Ajay K.
Carroll, Kevin
McMurray, John J. V.
Solomon, Scott
Jha, Vivekanand
Johansen, Kirsten L.
Lopes, Renato D.
Macdougall, Iain C.
Waikar, Sushrut S.
Wanner, Christoph
Wheeler, David C.
Więcek, Andrzej
Blackorby, Allison
Cizman, Borut
Cobitz, Alexander R.
Davies, Rich
DiMino, Tara L.
Kler, Lata
Meadowcroft, Amy M.
Taft, Lin
Perkovic, Vlado
Type
Resource Types::text::journal::journal article
Abstract
Background: Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. In patients with chronic kidney disease (CKD) who are not undergoing dialysis, the efficacy and safety of daprodustat, as compared with the conventional erythropoiesis-stimulating agent darbepoetin alfa, are unknown. Methods: In this randomized, open-label, phase 3 trial with blinded adjudication of cardiovascular outcomes, we compared daprodustat with darbepoetin alfa for the treatment of anemia in patients with CKD who were not undergoing dialysis. The primary outcomes were the mean change in the hemoglobin level from baseline to weeks 28 through 52 and the first occurrence of a major adverse cardiovascular event (MACE; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke). Copyright © 2021 Massachusetts Medical Society.