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

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  • David C. Wheeler
  • Bergur V. Stefansson
  • Mikhail Batiushin
  • Oleksandr Bilchenko
  • David Z.I. Cherney
  • Glenn M. Chertow
  • Walter Douthat
  • Jamie P. Dwyer
  • Elizabeth Escudero
  • Roberto Pecoits-Filho
  • Hans Furuland
  • José Luis Górriz
  • Tom Greene
  • Hermann Haller
  • Fan Fan Hou
  • Shin Wook Kang
  • Rey Isidto
  • Dinesh Khullar
  • Patrick B. Mark
  • John J.V. McMurray
  • Naoki Kashihara
  • Michal Nowicki
  • Frederik Persson
  • Ricardo Correa-Rotter
  • Peter Rossing
  • Robert D. Toto
  • Kausik Umanath
  • Pham Van Bui
  • István Wittmann
  • Magnus Lindberg
  • C. David Sjöström
  • Anna Maria Langkilde
  • Hiddo J.L. Heerspink
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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.

Original languageEnglish
JournalNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
Volume35
Issue number10
Pages (from-to)1700-1711
Number of pages12
ISSN0931-0509
DOIs
Publication statusPublished - 1 Oct 2020

Bibliographical note

© The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA.

    Research areas

  • chronic kidney disease, dapagliflozin, randomized controlled clinical trial, sodium–glucose co-transporter-2 inhibitor

ID: 61156300