TY - JOUR
T1 - The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial
T2 - Baseline characteristics
AU - Wheeler, David C.
AU - Stefansson, Bergur V.
AU - Batiushin, Mikhail
AU - Bilchenko, Oleksandr
AU - Cherney, David Z.I.
AU - Chertow, Glenn M.
AU - Douthat, Walter
AU - Dwyer, Jamie P.
AU - Escudero, Elizabeth
AU - Pecoits-Filho, Roberto
AU - Furuland, Hans
AU - Górriz, José Luis
AU - Greene, Tom
AU - Haller, Hermann
AU - Hou, Fan Fan
AU - Kang, Shin Wook
AU - Isidto, Rey
AU - Khullar, Dinesh
AU - Mark, Patrick B.
AU - McMurray, John J.V.
AU - Kashihara, Naoki
AU - Nowicki, Michal
AU - Persson, Frederik
AU - Correa-Rotter, Ricardo
AU - Rossing, Peter
AU - Toto, Robert D.
AU - Umanath, Kausik
AU - van Bui, Pham
AU - Wittmann, István
AU - Lindberg, Magnus
AU - David Sjöström, C.
AU - Langkilde, Anna Maria
AU - Heerspink, Hiddo J.L.
N1 - Publisher Copyright:
© The Author(s) 2020.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - 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.
AB - 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.
KW - Chronic kidney disease
KW - Dapagliflozin
KW - Randomized controlled clinical trial
KW - Sodium–glucose co-transporter-2 inhibitor
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U2 - 10.1093/ndt/gfaa234
DO - 10.1093/ndt/gfaa234
M3 - Article
C2 - 32862232
AN - SCOPUS:85092553819
SN - 0931-0509
VL - 35
SP - 1700
EP - 1711
JO - Nephrology Dialysis Transplantation
JF - Nephrology Dialysis Transplantation
IS - 10
ER -