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: 22 Feb 2024
Price :
$35
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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
- 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
- 05 Dec 2023 Results of post-hoc pooled analysis of two studies (NCT02540993 and NCT02545049) assessing the proportion of kidney and cardiovascular risk reductions seen over a 4-year period mediated by a change in kidney injury, as measured by the change in log UACR between baseline and month 4, published in the Annals of Internal Medicine.