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Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial
Journal
Nephrology Dialysis Transplantation
ISSN
0931-0509
1460-2385
Date Issued
2021
Author(s)
Singh, Ajay K.
Blackorby, Allison
Cizman, Borut
Carroll, Kevin
Cobitz, Alexander R.
Davies, Rich
Jha, Vivekanand
Johansen, Kirsten L.
Lopes, Renato D.
Kler, Lata
Macdougall, Iain C.
McMurray, John J. V.
Meadowcroft, Amy M.
Perkovic, Vlado
Solomon, Scott
Wanner, Christoph
Waikar, Sushrut S.
Wheeler, David C.
Wiecek, Andrzej
Type
Resource Types::text::journal::journal article
Abstract
Background: The Anemia Studies in chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Dialysis (ASCEND-D) trial will test the hypothesis that daprodustat is noninferior to comparator epoetin alfa or darbepoetin alfa for two co-primary endpoints: hemoglobin (Hb) efficacy and cardiovascular (CV) safety. Methods: We report the trial design, key demographic, clinical and laboratory findings, and baseline therapies of 2964 patients randomized in the open-label (sponsor-blinded) active-controlled, parallel-group, randomized ASCEND-D clinical trial. We also compare baseline characteristics of ASCEND-D patients with patients who are on dialysis (CKD G5D) enrolled in other large CV outcome trials (CVOTs) and in the most relevant registries. © The Author(s) 2021. Published by Oxford University Press on behalf of the ERA-EDTA.