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Obrador, Gregorio
Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial
The ASCEND-ND trial: study design and participant characteristics
2021
,
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.
,
Obrador, Gregorio
,
Perkovic, Vlado
,
Solomon, Scott
,
Wanner, Christoph
,
Waikar, Sushrut S.
,
Wheeler, David C.
,
Wiecek, Andrzej
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.
2021
,
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.
,
Obrador, Gregorio
,
Solomon, Scott
,
Taft, Lin
,
Wanner, Christoph
,
Waikar, Sushrut S.
,
Wheeler, David C.
,
Wiecek, Andrzej
,
Singh, Ajay K.
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.