FINE‑ONE: Finerenone Lowers Albuminuria But Raises Hyperkalemia in Type 1 Diabetes CKD

A phase 3 abstract reports results of finerenone in adults with type 1 diabetes and chronic kidney disease, focusing on changes in albuminuria alongside short-term safety signals over a 6-month treatment window.

The primary measurement was the relative change in urinary albumin-to-creatinine ratio (UACR) at 6 months. The abstract also summarizes hyperkalemia frequency and describes an early change in estimated glomerular filtration rate (eGFR) during treatment, with additional observation during washout. Overall, it describes what was observed in this type 1 diabetes CKD population over the trial’s stated timeframe.

Eligibility criteria specify adults with type 1 diabetes and CKD, with eGFR 25 to <90 ml/min/1.73 m2 and UACR 200 to <5000 mg/g, all receiving background angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker therapy. In the phase 3 FINE‑ONE trial, participants were randomized to finerenone or matching placebo, with finerenone dosed at 10 or 20 mg daily according to eGFR; 242 participants underwent randomization. The abstract identifies the primary endpoint as the relative change in UACR over 6 months, pairing this short-term albuminuria readout with safety observations reported alongside it.

For the primary endpoint at 6 months, the abstract reports that UACR decreased by 34% with finerenone (geometric mean ratio to baseline, 0.66; 95% CI, 0.60 to 0.73) and by 12% with placebo (geometric mean ratio to baseline, 0.88; 95% CI, 0.79 to 0.98), corresponding to a 25% greater reduction with finerenone than with placebo (geometric mean ratio for finerenone vs placebo, 0.75; 95% CI, 0.65 to 0.87; P<0.001). Across the prespecified 6-month period, results showed a larger reduction in albuminuria with finerenone than with placebo, characterized in the abstract as statistically significant at 6 months.

Safety and kidney function findings are also summarized. Hyperkalemia was reported as the most common adverse event, occurring in 12 participants (10.1%) receiving finerenone and 4 (3.3%) receiving placebo, and 2 participants (1.7%) discontinued finerenone because of hyperkalemia. At 6 months, the change in eGFR was −5.6 ml/min/1.73 m2 with finerenone and −2.7 ml/min/1.73 m2 with placebo (between-group difference, −2.9 ml/min/1.73 m2; 95% CI, −5.1 to −0.7), and the abstract notes that eGFR values approached baseline levels during the washout period. With a UACR-based primary endpoint at 6 months, the abstract’s scope constrains what can be concluded from these data about longer-term kidney outcomes beyond the reported window. In combination, the abstract describes more frequent hyperkalemia with finerenone and an early eGFR decline that was reported to move back toward baseline during washout.

Key Takeaways:

• The abstract reports greater UACR reduction with finerenone than with placebo at 6 months in adults with type 1 diabetes and CKD.
• Hyperkalemia was reported more often with finerenone and, in some cases, led to discontinuation in the finerenone group.
• An early eGFR decline was observed with finerenone and was described as approaching baseline during washout, within the short follow-up window reported in the abstract.