Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has demonstrated kidney and cardiovascular benefits in individuals with type 2 diabetes (T2DM) and chronic kidney disease (CKD). Whether similar effects occur in persons with type 1 diabetes (T1DM) and CKD has remained uncertain. Findings from the FINE-ONE phase 3 randomized trial, published in the New England Journal of Medicine, evaluated the efficacy and safety of finerenone in adults with T1DM and CKD receiving background renin-angiotensin system inhibition.

The trial enrolled 242 adults with T1DM, CKD with an estimated glomerular filtration rate (eGFR) of 25 to <90 mL/min/1.73 m², and albuminuria with urinary albumin-to-creatinine ratio (UACR) of 200 to <5000. Participants were receiving either an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and were randomly assigned to finerenone (10 or 20 mg daily based on eGFR) or matching placebo. The primary endpoint was the relative change in UACR after 6 months.

Median UACR declined from 574.6 to 373.5 among participants receiving finerenone and from 506.4 to 475.6 among those receiving placebo. Over six months, UACR decreased by 34% with finerenone and 12% with placebo, corresponding to a 25% greater reduction with finerenone (geometric mean ratio 0.75; 95% CI 0.65-0.87; P < 0.001). Hyperkalemia occurred in 10.1% of participants receiving finerenone and 3.3% receiving placebo, with two participants discontinuing finerenone because of hyperkalemia. Mean eGFR declined by −5.6 mL/min/1.73 m² with finerenone and −2.7 mL/min/1.73 m² with placebo, although eGFR values approached baseline levels during the washout period.

Overall, finerenone produced a significantly larger reduction in albuminuria than placebo in adults with T1DM and CKD receiving background ACE inhibitor or ARB therapy.