The ASCEND-ND trial: study design and participant characteristics
Journal
Nephrology Dialysis Transplantation
ISSN
0931-0509
1460-2385
Date Issued
2021
Author(s)
Perkovic, Vlado
Blackorby, Allison
Cizman, Borut
Carroll, Kevin
Cobitz, Alexander R.
Davies, Rich
DiMino, Tara L.
Jha, Vivekanand
Johansen, Kirsten L.
Lopes, Renato D.
Kler, Lata
Macdougall, Iain C.
McMurray, John J. V.
Meadowcroft, Amy M.
Solomon, Scott
Taft, Lin
Wanner, Christoph
Waikar, Sushrut S.
Wheeler, David C.
Wiecek, Andrzej
Singh, Ajay K.
Type
text::journal::journal article
Abstract
Background: Anaemia is common in chronic kidney disease (CKD) and assessment of the risks and benefits of new therapies is important. Methods: The Anaemia Study in CKD: Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) trial includes adult patients with CKD Stages 3-5, not using erythropoiesis-stimulating agents (ESAs) with screening haemoglobin (Hb) 8-10 g/dL or receiving ESAs with screening Hb of 8-12 g/dL. Participants were randomized to daprodustat or darbepoetin alfa (1:1) in an open-label trial (steering committee- and sponsor-blinded), with blinded endpoint assessment. The co-primary endpoints are mean change in Hb between baseline and evaluation period (average over Weeks 28-52) and time to first adjudicated major adverse cardiovascular (CV) event. Baseline characteristics were compared with those of participants in similar anaemia trials. © The Author(s) 2021. Published by Oxford University Press on behalf of the ERA.