Title
The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: Baseline characteristics
Date Issued
01 October 2020
Access level
open access
Resource Type
journal article
Author(s)
Wheeler D.C.
Stefansson B.V.
Batiushin M.
Bilchenko O.
Cherney D.Z.I.
Chertow G.M.
Douthat W.
Dwyer J.P.
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.
Publisher(s)
Oxford University Press
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 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.
Start page
1700
End page
1711
Volume
35
Issue
10
Language
English
OCDE Knowledge area
Ciencias médicas, Ciencias de la salud Urología, Nefrología
Scopus EID
2-s2.0-85092553819
PubMed ID
Source
Nephrology Dialysis Transplantation
ISSN of the container
09310509
Sources of information: Directorio de Producción Científica Scopus