Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial

Ajay K Singh, Allison Blackorby, Borut Cizman, Kevin Carroll, Alexander R Cobitz, Rich Davies, Vivekanand Jha, Kirsten L Johansen, Renato D Lopes, Lata Kler, Iain C Macdougall, John J V McMurray, Amy M Meadowcroft, Gregorio T Obrador, Vlado Perkovic, Scott Solomon, Christoph Wanner, Sushrut S Waikar, David C Wheeler, Andrzej Wiecek, Ajay K Singh, Allison Blackorby, Borut Cizman, Kevin Carroll, Alexander R Cobitz, Rich Davies, Vivekanand Jha, Kirsten L Johansen, Renato D Lopes, Lata Kler, Iain C Macdougall, John J V McMurray, Amy M Meadowcroft, Gregorio T Obrador, Vlado Perkovic, Scott Solomon, Christoph Wanner, Sushrut S Waikar, David C Wheeler, Andrzej Wiecek

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.

Results: The median age of patients was 58 years, 43% were female; 67% were White and 16% were Black. The median Hb at baseline was 10.4 g/dL. Among randomized patients, 89% were receiving hemodialysis and 11% peritoneal dialysis. Among key comorbidities, 42% reported a history of diabetes mellitus and 45% a history of CV disease. Median blood pressure was 134/74 mmHg. The median weekly dose of epoetin was 5751 units. Intravenous and oral iron uses were noted in 64 and 11% of patients, respectively. Baseline demographics were similar to patients with CKD G5D enrolled in other CVOTs and renal patient registries.

Conclusions: ASCEND-D will evaluate the efficacy and safety of daprodustat compared with epoetin alfa or darbepoetin alfa in the treatment of patients with anemia with CKD G5D.This trial is registered with ClinicalTrials.gov: NCT02879305. EudraCT Number: 2016-000541-31; Sponsor Protocol Number: 200807.

Keywords: anemia; baseline data; daprodustat; dialysis; recombinant human erythropoietin.

© The Author(s) 2021. Published by Oxford University Press on behalf of the ERA-EDTA.

Figures

Graphical Abstract
Graphical Abstract
FIGURE 1
FIGURE 1
ASCEND-D study design. Serum and plasma samples are collected at baseline, Week 28 and Week 52 for future analysis of biomarkers of CV risk and iron metabolism.

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Source: PubMed

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