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DAPA-CKD: dapagliflozin in chronic kidney disease

A large trial of people with chronic kidney disease, with or without type 2 diabetes. Half took dapagliflozin 10 mg a day and half took placebo. The monitoring committee recommended stopping the trial early because dapagliflozin was working. It lowered the risk of kidney failure, a large fall in kidney function, or death from a kidney or heart cause, and the effect was similar with and without diabetes.

Also called DAPA-CKD

  • Study
  • In this atlas

Overview

Design
Randomized, double-blind, placebo-controlled, parallel-group trial. The registry records phase 3 and quadruple masking.
Phase
Phase 3
Enrolled
  • 4,304 participants (enrolled count) (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03036150
Started
(actual) (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease, retrieved )
Primary completion
(actual) (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease, retrieved )
Completion
(actual) (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease, retrieved )
Results first posted
(actual) (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease, retrieved )
Countries
United States, Argentina, Brazil, Canada, China, Denmark, Germany, Hungary, India, Japan, Mexico, Peru, Philippines, Poland, Russia, South Korea, Spain, Sweden, Ukraine, United Kingdom, Vietnam (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )
Stopped early
The trial stopped early, date not reported. The independent data monitoring committee recommended stopping the trial because of efficacy. The registry records the study as completed. (Dapagliflozin in Patients with Chronic Kidney Disease, retrieved )

Technical summary

Randomized, double-blind, placebo-controlled trial sponsored by AstraZeneca (NCT03036150). 4304 participants with an eGFR of 25 to 75 and a urinary albumin-to-creatinine ratio of 200 to 5000. Median follow-up 2.4 years. Primary outcome (sustained eGFR decline of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes): 197 of 2152 (9.2%) against 312 of 2152 (14.5%), hazard ratio 0.61 (95% CI 0.51 to 0.72; P<0.001).

Arms

  • Dapagliflozin

    Intervention None named

    Dapagliflozin 10 mg once daily.

  • Placebo

    Intervention None named

    Placebo.

Findings

No findings are published for this study.

Record details

Record id
cardio:dapa-ckd
Content hash
ba3a65752a52aa2247d9e2c08502216003cc6ce2ad77f783fb43ab860b64f3e6