Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial

DAPA-CKD Investigators, Hiddo J. L. Heerspink*, Bergur Stefansson, Glenn M. Chertow, Ricardo Correa-Rotter, Tom Greene, Fan-Fan Hou, Magnus Lindberg, John McMurray, Peter Rossing, Roberto Toto, Anna Maria Langkilde, David C. Wheeler

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background. Recent cardiovascular outcome trials have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease (CKD) in patients with type 2 diabetes at high cardiovascular risk. Whether these benefits extend to CKD patients without type 2 diabetes or cardiovascular disease is unknown. The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes. Methods. DAPA-CKD is a randomized, double-blind, placebo-controlled, trial in which -4300 patients with CKD Stages 2-4 and elevated urinary albumin excretion will be enrolled. The vast majority will be receiving a maximum tolerated dose of a renin-angiotensin system inhibitor at enrolment. Results. After a screening assessment, eligible patients with a urinary albumin:creatinine ratio =200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/ 1.73 m2 are randomly assigned to placebo or dapagliflozin 10 mg/day. Enrolment is monitored to ensure that at least 30% of patients do not have diabetes and that no more than 10% have an eGFR >60 mL/min/1.73 m2. The primary endpoint is a composite of a sustained decline in eGFR of =50%, end-stage renal disease, renal death or cardiovascular death. The trial will conclude when 681 primary renal events have occurred, providing 90% power to detect a 22% relative risk reduction (a level of 0.05). Conclusion. DAPA-CKD will determine whether the SGLT2 inhibitor dapagliflozin, added to guideline-recommended therapies, safely reduces the rate of renal and cardiovascular events in patients across multiple CKD stages with and without diabetes.

Original languageEnglish
Pages (from-to)274-282
Number of pages9
JournalNephrology Dialysis Transplantation
Volume35
Issue number2
DOIs
Publication statusPublished - Feb-2020

Keywords

  • chronic kidney disease
  • dapagliflozin
  • randomized controlled clinical trial
  • sodium-glucose co-transporter inhibitor
  • INHIBITORS

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