Cardiovascular Atlas
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FIDELIO-DKD: finerenone and kidney outcomes in type 2 diabetes

A large trial of people with chronic kidney disease and type 2 diabetes. Half took finerenone and half took placebo, on top of the usual blood-pressure medicines that act on the renin-angiotensin system. Finerenone lowered the risk of kidney failure, a large fall in kidney function, or death from a kidney cause, and lowered the risk of a combined heart outcome. High potassium led to stopping the trial medicine more often on finerenone.

Also called FIDELIO-DKD

  • Study
  • In this atlas

Overview

Design
Randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven trial (registry official title). The registry records phase 3 and quadruple masking.
Phase
Phase 3
Enrolled
  • 5,734 participants (enrolled count) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT02540993
Started
(actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, retrieved )
Primary completion
(actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, retrieved )
Completion
(actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, retrieved )
Results first posted
(actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam, Türkiye, Hong Kong SAR China (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Randomized, double-blind trial sponsored by Bayer (NCT02540993). 5734 patients with chronic kidney disease and type 2 diabetes were randomized 1:1; median follow-up 2.6 years. Primary outcome (kidney failure, a sustained decrease of at least 40% in eGFR, or death from renal causes): 504 of 2833 (17.8%) against 600 of 2841 (21.1%), hazard ratio 0.82 (95% CI 0.73 to 0.93; P=0.001). Key secondary cardiovascular outcome: hazard ratio 0.86 (95% CI 0.75 to 0.99).

Arms

  • Finerenone

    Intervention Finerenone

    Finerenone (registry code BAY94-8862) in addition to standard of care, including renin-angiotensin system blockade.

  • Placebo

    Intervention None named

    Placebo in addition to standard of care.

Findings

No findings are published for this study.

Record details

Record id
cardio:fidelio-dkd
Content hash
5bb9846f6508e94155e2e5ed5645b837e4f0a3d92d13a5b633fc1275b165efc5