Finerenone Marks a Breakthrough for Kidney Protection in Type 1 Diabetes, with Janet McGill, MD, MA

Use of finerenone was associated with a statistically significant 25% relative reduction in urine albumin-to-creatinine ratio compared with placebo over 6 months in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD).

These findings, from the FINE-ONE trial, were presented at the American Society of Nephrology (ASN) Kidney Week 2025, held November 5-9, 2025, in Houston, Texas, by Janet B. McGill, MD, MA, Professor of Medicine, Washington University in St. Louis, Missouri.

The FINE-ONE trial (NCT05901831) is a global, double-blind, phase 3 study evaluating the efficacy and safety of finerenone in patients with T1D, CKD, and albuminuria. The trial enrolled 242 patients, most with over 30 years of diabetes, reflecting the long disease burden typical of this population. At baseline, participants had a mean estimated glomerular filtration rate (eGFR) of 59 mL/min/1.73 m² and a median urine albumin-to-creatinine ratio (UACR) of 549 mg/g.

The starting dose of finerenone was based on estimated glomerular filtration rate (eGFR), with participants with eGFR ≥25 - <60 mL/min/1.73 m² receiving 10 mg once daily and participants with eGFR ≥60 mL/min/1.73 m² receiving 20 mg once daily. After 30 days, uptitration to the 20 mg target dose was permitted if serum/plasma potassium was ≤4.8 mmol/L and eGFR decline was <30% compared with the prior visit.

The primary endpoint was the relative change in UACR from baseline over 6 months. Finerenone treatment achieved a 25% relative reduction in UACR compared with placebo (least squares geometric mean [LSGM] ratio 0.75; 95% CI, 0.65–0.87; P = .0001).

Results also suggested, at any time post-baseline, 68.1% (81/119) of participants in the finerenone arm achieved at least a 30% reduction in UACR, compared with 46.6% (54/116) of participants in the placebo arm. In their press release announcing results, Bayer highlighted this threshold aligns with American Diabetes Association guidance identifying ≥30% UACR reduction as a marker associated with slower progression in diabetic kidney disease.

HCPLive spoke with McGill to learn more about the new data and how finerenone might help fill an unmet need in the treatment landscapes of T1D and CKD.

"This is a very good indicator that finenerenone will have durable effects at reducing progression of progressive loss of kidney function in these patients. We're really very excited about this trial because of the huge gap in studies in T1D," McGill said.

McGill reported Bayer Healthcare Pharma as a relevant disclosure.

Reference

Heerspink HGL, Cherney D, Rossing P, Lawatscheck R, McGill JB. Finerenone in CKD and Type 1 Diabetes. Presented at: ASN Kidney Week. Houston, Texas. November 05-09, 2025. #TH-OR082