The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics

Wheeler, D. C. et al. (2020) The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics. Nephrology Dialysis Transplantation, 35(10), pp. 1700-1711. (doi: 10.1093/ndt/gfaa234) (PMID:32862232) (PMCID:PMC7538235)

Abstract

Background: The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD; NCT03036150) trial was designed to assess the effect of the sodium–glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on kidney and cardiovascular events in participants with CKD with and without type 2 diabetes (T2D). This analysis reports the baseline characteristics of those recruited, comparing them with those enrolled in other trials. Methods: In DAPA-CKD, 4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 were randomized to dapagliflozin 10 mg once daily or placebo. Mean eGFR was 43.1 mL/min/1.73 m2 and median UACR was 949 mg/g (108 mg/mmol). Results: Overall, 2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes. The most common causes of CKD after diabetes (n = 2510) were ischaemic/hypertensive nephropathy (n = 687) and chronic glomerulonephritis (n = 695), of which immunoglobulin A nephropathy (n = 270) was the most common. A total of 4174 participants (97%) were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8%) glucagon-like peptide 1 receptor agonists. In contrast to the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes. The mean eGFR of participants in the DAPA-CKD trial was 13.1 mL/min/1.73 m2 lower than in CREDENCE, similar to that in the Finerenone in Reducing Kidney Failure and Disease Progression in DKD (FIDELIO-DKD) trial and the Study Of diabetic Nephropathy with AtRasentan (SONAR). Conclusions: Participants with a wide range of underlying kidney diseases receiving renin–angiotensin system blocking therapy have been enrolled in the DAPA-CKD trial. The trial will examine the efficacy and safety of dapagliflozin in participants with CKD Stages 2–4 and increased albuminuria, with and without T2D.

• Item Type: Articles
• Additional Information: This study was funded by AstraZeneca.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Mark, Professor Patrick and McMurray, Professor John
• Authors: Wheeler, D. C., Stefansson, B. V., Batiushin, M., Bilchenko, O., Cherney, D. Z.I., Chertow, G. M., Douthat, W., Dwyer, J. P., Escudero, E., Pecoits-Filho, R., Furuland, H., Górriz, J. L., Greene, T., Haller, H., Hou, F. F., Kang, S.-W., Isidto, R., Khullar, D., Mark, P. B., McMurray, J. J.V., Kashihara, N., Nowicki, M., Persson, F., Correa-Rotter, R., Rossing, P., Toto, R. D., Umanath, K., Van Bui, P., Wittmann, I., Lindberg, M., Sjöström, C. D., Langkilde, A. M., and Heerspink, H. J.L.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Nephrology Dialysis Transplantation
• Publisher: Oxford University Press
• ISSN: 0931-0509
• ISSN (Online): 1460-2385
• Published Online: 30 August 2020
• Copyright Holders: Copyright © 2020 The Authors
• First Published: First published in Nephrology Dialysis Transplantation 35(10): 1700-1711
• Publisher Policy: Reproduced under a Creative Commons License