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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs Finerenone (Primary)
  • Indications Cardiovascular disorders; Diabetic nephropathies; Renal failure
  • Focus Registrational; Therapeutic Use
  • Acronyms FIDELIO-DKD
  • Sponsors Bayer

Most Recent Events

  • 25 Mar 2025 According to Bayer media release, data from this trial will be presented at the American College of Cardiology (ACC) 74th Annual Scientific Session & Expo 2025
  • 22 Feb 2024 Results assessing dose-exposure-response analyses to determine the effects of finerenone doses in FIGARO-DKD and FIDELIO-DKD trials, published in the Diabetes, Obesity and Metabolism.
  • 01 Jan 2024 Results of pooled, subgroup analysis from FIDELIO-DKD and FIGARO-DKD; investigating the effect of finerenone on liver function, cardiovascular and kidney composite outcomes in patients with chronic kidney disease and type 2 diabetes, stratified by their risk of liver steatosis, inflammation and fibrosis, published in the Diabetes, Obesity and Metabolism

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