The ASCEND-ND trial: study design and participant characteristics

Perkovic, V. et al. (2022) The ASCEND-ND trial: study design and participant characteristics. Nephrology Dialysis Transplantation, 37(11), pp. 2157-2170. (doi: 10.1093/ndt/gfab318) (PMID:34865143) (PMCID:PMC9585467)

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 randomised 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 to 52) and time to first adjudicated major adverse cardiovascular (CV) event. Baseline characteristics were compared with those of participants in similar anaemia trials. Results: Overall, 3872 patients were randomised from 39 countries (median age 67 years, 56% female; 56% White, 27% Asian, and 10% Black). Median baseline Hb was 9.9 g/dL, blood pressure was 135/74 mmHg and eGFR was 18 mL/min/1.73 m2. Among randomised patients, 53% were ESA non-users, 57% had diabetes and 37% had a history of CV disease. At baseline, 61% of participants were using renin– angiotensin system blockers, 55% were taking statin and 49% oral iron. Baseline demographics were similar to those in other large non-dialysis anaemia trials. Conclusion: ASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not on dialysis.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McMurray, Professor John
• Authors: Perkovic, V., Blackorby, A., Cizman, B., Carroll, K., Cobitz, A. R., Davies, R., DiMino, T. L., Jha, V., Johansen, K. L., Lopes, R. D., Kler, L., Macdougall, I. C., McMurray, J. J.V., Meadowcroft, A. M., Obrador, G. T., Solomon, S., Taft, L., Wanner, C., Waikar, S. S., Wheeler, D. C., Wiecek, A., and Singh, A. K.
• 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: 02 December 2021
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in Nephrology Dialysis Transplantation 37(11): 2157-2170
• Publisher Policy: Reproduced under a Creative Commons License