Previous randomized trials demonstrated benefits of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, on kidney and cardiovascular outcomes in patients with type 2 diabetes and chronic kidney disease (CKD). This trial tested whether finerenone provides similar renal and cardiovascular effects in adults who have CKD without diabetes.
This was a randomized, multicenter trial published in the New England Journal of Medicine. Adults without diabetes were eligible if they had an estimated glomerular filtration rate (eGFR) between 25 and <90 ml per minute per 1.73 m2 and albuminuria defined as a urinary albumin-to-creatinine ratio of 200 to ≤3500 (albumin in milligrams and creatinine in grams). All participants were required to be receiving a renin–angiotensin system inhibitor at baseline.
A total of 1,584 participants were randomized: 793 to the finerenone group and 791 to placebo. The mean (±SD) baseline eGFR was 46.8±16.2 ml/min/1.73 m2 in the finerenone group and 46.6±16.0 ml/min/1.73 m2 in the placebo group.
Participants received either finerenone (dosed at 10 or 20 mg once daily) or matching placebo. Randomization allocated roughly equal numbers to each arm. Further details on dose-titration rules, adherence, or randomization stratification were not reported in the provided abstract.
The prespecified primary outcome was the total eGFR slope, defined as the mean annual rate of change in the eGFR from baseline to month 32. The analysis used a two-slope linear spline mixed-effects model.
Over the 32-month period, the mean annual rate of eGFR change was -3.3 ml/min/1.73 m2 (95% CI, -3.6 to -3.1) in the finerenone group and -4.0 ml/min/1.73 m2 (95% CI, -4.3 to -3.8) in the placebo group. The between-group difference was 0.7 ml/min/1.73 m2 per year (95% CI, 0.3 to 1.1; P<0.001), indicating a statistically significant slower decline in eGFR with finerenone compared with placebo.
Secondary outcomes included a hierarchical set of composite events:
Prespecified hierarchical testing showed a lower risk of the composite kidney or cardiovascular outcome with finerenone than with placebo (hazard ratio, 0.77; 95% CI, 0.60 to 0.99; P = 0.04). The hazard ratio for the kidney composite was 0.78 (95% CI, 0.60 to 1.01), and for the cardiovascular composite it was 0.60 (95% CI, 0.27 to 1.33). The confidence intervals for the two component composites include 1.0, indicating that those comparisons did not meet conventional statistical significance in the summary data provided.
The most commonly reported adverse event was hyperkalemia. Hyperkalemia occurred in 135 participants (17.0%) in the finerenone group and in 105 participants (13.3%) in the placebo group. Hyperkalemia led to discontinuation of the trial regimen in 12 participants (1.5%) receiving finerenone and in 1 participant (0.1%) receiving placebo. Hospitalization for hyperkalemia occurred in 7 participants (0.9%) with finerenone and 5 participants (0.6%) with placebo.
Other adverse events, detailed safety subgroup analyses, or laboratory-parameter trajectories beyond hyperkalemia were not reported in the abstract extract and are therefore not available here.
Among adults with CKD who did not have diabetes, finerenone produced a statistically significant slowing in the rate of eGFR decline over 32 months compared with placebo. A prespecified composite of kidney or cardiovascular outcomes was reduced with finerenone (hazard ratio 0.77; 95% CI, 0.60 to 0.99). The trial was funded by Bayer and registered at ClinicalTrials.gov (NCT05047263).
The provided source text is the PubMed abstract and does not include full-text details. Information not reported in the abstract extract includes, but may not be limited to:
Readers should consult the full trial publication for complete methods, supplementary analyses, and comprehensive safety data.