Cardiovascular Atlas
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EMPA-KIDNEY: empagliflozin in a broad range of chronic kidney disease

A large trial of people with chronic kidney disease who were at risk of it getting worse, with or without diabetes. Half took empagliflozin 10 mg a day and half took placebo. Empagliflozin lowered the risk of kidney disease getting worse or death from a heart cause. Fewer people were admitted to hospital for any reason. Deaths from any cause did not differ significantly. The trial was stopped early at a planned interim analysis.

Also called EMPA-KIDNEY

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, double-blind, placebo-controlled, multicenter international trial (registry official title). The registry records phase 3 and double masking.
Phase
Phase 3
Enrolled
  • 6,609 participants (enrolled count) (EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin), retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03594110
Started
(actual) (EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin), retrieved )
Primary completion
(actual) (EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin), retrieved )
Completion
(actual) (EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin), retrieved )
Results first posted
(actual) (EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin), retrieved )
Countries
United States, Canada, China, Germany, Italy, Japan, Malaysia, United Kingdom (EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin), 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 data and safety monitoring board reported at a formal interim analysis that both conditions for stopping early for efficacy were met. The registry records the study as completed. (Empagliflozin in Patients with Chronic Kidney Disease, retrieved )

Technical summary

Randomized, double-blind, placebo-controlled trial sponsored by Boehringer Ingelheim, with the University of Oxford and Eli Lilly as registry collaborators (NCT03594110). 6609 patients were randomized; median follow-up 2.0 years. Primary outcome (progression of kidney disease or death from cardiovascular causes): 432 of 3304 (13.1%) against 558 of 3305 (16.9%), hazard ratio 0.72 (95% CI 0.64 to 0.82; P<0.001). The trial was stopped early for efficacy at a formal interim analysis (PMC full text).

Arms

  • Empagliflozin 10 mg

    Intervention None named

    Empagliflozin 10 mg once daily.

  • Placebo

    Intervention None named

    Matching placebo.

Findings

No findings are published for this study.

Record details

Record id
cardio:empa-kidney
Content hash
418efed405be3e5be26b65d7c01b893e42f536b4b3db9bc168a1c632b90a3594