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

Study · id `cardio:fidelio-dkd` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: FIDELIO-DKD

Browse, organ or system: Kidneys  
Browse, condition area: Diabetes and metabolic disease; Kidney connections  

## In plain language

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.

## 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).

## Key facts

- 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: 5734 participants (enrolled count; Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)
- Started: 2015-09-17 (actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2020-04-14 (actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)
- Completion: 2020-04-14 (actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2021-07-19 (actual) (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease, snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)
- 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, snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct02540993-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests finerenone: Finerenone (`cardio:finerenone`)
- Lists chronic kidney disease as its condition: Chronic kidney disease (CKD) (`cardio:chronic-kidney-disease`)
- Enrolled people with chronic kidney disease and type 2 diabetes: Type 2 diabetes (`cardio:type-2-diabetes`)
- Lead sponsor: Bayer (`cardio:bayer`)
- Names a sustained eGFR decrease in its primary outcome: Estimated glomerular filtration rate (eGFR) (`cardio:egfr`)

## Provenance

Content hash: e7e66da13281bf9b17f9f1705d202f739a684829512bb9b53734b38439623d77
Last substantive edit: 2026-10-15
Evidence last checked: Not recorded