Singh, A. K. et al. (2022) Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrology Dialysis Transplantation, 37(5), pp. 960-972. (doi: 10.1093/ndt/gfab065) (PMID:33744933)
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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 |
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Status: | Published |
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. J.V., 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 > School of Cardiovascular & Metabolic Health |
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 37(5): 960-972 |
Publisher Policy: | Reproduced under a Creative Commons License |
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