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

Singh, A. K. et al. (2021) Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrology Dialysis Transplantation, (doi: 10.1093/ndt/gfab065) (PMID:33744933) (Early Online Publication)

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Abstract

Background: The Anemia Studies in chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor (PHI) Daprodustat-Dialysis (ASCEND-D) trial will test the hypothesis that daprodustat is non-inferior to comparator epoetin alfa or darbepoetin alfa for two co-primary endpoints: haemoglobin efficacy and cardiovascular safety. Methods: We report the trial design, key demographic, clinical, and laboratory findings, and baseline therapies of 2964 patients randomised in the open-label (sponsor-blinded) active-controlled, parallel-group, randomised 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 cardiovascular 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 haemoglobin at baseline was 10.4 g/dL. Among randomised patients, 89% were receiving haemodialysis and 11% peritoneal dialysis. Among key co-morbidities, 42% reported a history of diabetes mellitus, and 45% a history of cardiovascular disease. Median blood pressure was 134/74 mmHg. The median weekly dose of epoetin was 5751 units. Intravenous and oral iron use was 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. Conclusion: ASCEND-D will evaluate the efficacy and safety of daprodustat compared with epoetin alfa or darbepoetin alfa in the treatment of patients with anaemia with CKD G5D.

Item Type:Articles
Status:Early Online Publication
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Singh, A. K., Blackorby, A., Cizman, B., Carroll, K., Cobitz, A. R., Davies, R., Jha, V., Johansen, K. L., Lopes, R. D., Kler, L., Macdougall, I. C., McMurray, J., Meadowcroft, A. M., Obrador, G. T., Perkovic, V., Solomon, S., Wanner, C., Waikar, S. S., Wheeler, D. C., and Wiecek, A.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Nephrology Dialysis Transplantation
Publisher:Oxford University Press
ISSN:0931-0509
ISSN (Online):1460-2385
Published Online:21 March 2021
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in Nephrology Dialysis Transplantation 2021
Publisher Policy:Reproduced under a Creative Commons License

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