FIDELIO-DKD: what the trial showed
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. Results are summarized from the cited trial report and any companion publications listed below.
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 | Placebo | Effect |
|---|---|---|
| 17.8% (504 of 2,833) | 21.1% (600 of 2,841) | 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
Written for healthcare professionals as an orientation to the primary publication, not as a substitute for reading it. For literature search, education, and professional evidence review only. Not for diagnosis, treatment selection, triage, monitoring, prognosis, or patient-specific clinical decision-making.