# FIDELIO-DKD: what the trial showed

Canonical page: https://cliniatlas.com/trials/fidelio-dkd/

In 5,734 patients with chronic kidney disease and type 2 diabetes already on maximal RAS blockade, finerenone reduced the composite of kidney failure, sustained 40% eGFR decline, or renal death from 21.1% to 17.8% over a median of 2.6 years, at the cost of more hyperkalaemia.

**Main cited publication:** Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. New England Journal of Medicine (2020). PMID 33264825. https://pubmed.ncbi.nlm.nih.gov/33264825/

## At a glance

- Design: Randomised, double-blind, placebo-controlled, event-driven
- Population: 5,734 adults with type 2 diabetes and CKD defined by albuminuria (UACR 30 to <300 mg/g with eGFR 25 to <60 and diabetic retinopathy, or UACR 300 to 5,000 mg/g with eGFR 25 to <75), all on maximum tolerated labelled RAS blockade
- Intervention: Finerenone (nonsteroidal mineralocorticoid receptor antagonist), dose-adjusted
- Comparator: Placebo
- Follow-up: Median 2.6 years
- Registration: NCT02540993
- Funding: Bayer

## Primary outcome

Composite of kidney failure, sustained decrease of at least 40% in eGFR from baseline, or death from renal causes.

- Finerenone (nonsteroidal mineralocorticoid receptor antagonist), dose-adjusted: 17.8% (504 of 2,833)
- Placebo: 21.1% (600 of 2,841)
- Effect: Hazard ratio 0.82 (95% CI 0.73 to 0.93), P=0.001

## Key findings

- The key secondary cardiovascular composite (cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalisation) occurred in 13.0% versus 14.8% (HR 0.86, 95% CI 0.75 to 0.99, P=0.03).
- The absolute reduction in the kidney composite was about 3.3 percentage points over 2.6 years.
- The companion FIGARO-DKD trial, in patients with less advanced kidney disease, showed a cardiovascular benefit with the same drug.

## Harms and safety

- Hyperkalaemia-related discontinuation was more common with finerenone (2.3% versus 0.9%).
- Overall adverse event frequency was similar between groups.

## Limitations

- Enrolment required optimised RAS blockade and excluded patients with potassium above the entry threshold, so the hyperkalaemia risk in routine care may be higher.
- Few patients were on an SGLT2 inhibitor at baseline; the combined effect of finerenone and SGLT2 inhibition was not tested here.
- Industry funded.

## Where it sits in guidelines

The KDIGO 2022 guideline on diabetes management in CKD suggests a nonsteroidal MRA with proven kidney or cardiovascular benefit for adults with type 2 diabetes, eGFR of 25 or more, normal potassium, and albuminuria despite maximum tolerated RAS blockade (a 2A suggestion). Finerenone received EU marketing authorisation in 2022.

## CliniAtlas answers that use this trial

- https://cliniatlas.com/evidence/finerenone-chronic-kidney-disease-type-2-diabetes/

Ask about this trial against live sources (free, no sign-in): https://cliniatlas.com/?q=What%20did%20the%20FIDELIO-DKD%20trial%20show%20and%20how%20should%20it%20be%20interpreted%3F

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