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

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.; David Sjöström C.; Langkilde A.M.; Heerspink H.J.L. · Nephrology Dialysis Transplantation (2020) · DOI: 10.1093/ndt/gfaa234

Resumen

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 ¼ 2510) were ischaemic/hypertensive nephropathy (n ¼ 687) and chronic glomerulonephritis (n ¼ 695), of which immunoglobulin A nephropathy (n ¼ 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. © The Author(s) 2020.

Instituciones: Universidad Peruana Cayetano Heredia