Finerenone Reduces Albuminuria in Type 1 Diabetes with Chronic Kidney Disease
Key Highlights
- Finerenone achieved a 25% greater reduction in urinary albumin-to-creatinine ratio than placebo over 6 months.
- Hyperkalemia was more frequent with finerenone (10.1%) than placebo (3.3%).
- An early decline in eGFR with finerenone was partially reversed during washout.
- An accompanying editorial describes FINE-ONE as an important step forward but notes that larger, longer trials are needed before integrating finerenone into practice.
In a phase 3, double-blind, randomized, placebo-controlled trial published in The New England Journal of Medicine, finerenone significantly reduced albuminuria compared with placebo in adults with type 1 diabetes and chronic kidney disease (CKD).1 Over 6 months, finerenone added to the background angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy, which resulted in a 25% greater reduction in the urinary albumin-to-creatinine ratio than placebo.
The FINE-ONE trial enrolled 242 adults aged 18 years or older with type 1 diabetes and CKD, defined by an estimated glomerular filtration rate (eGFR) of 25 to less than 90 mL/min/1.73 m² and a urinary albumin-to-creatinine ratio of 200 to less than 5,000. Participants were required to receive a stable dose of an ACE inhibitor or ARB. Patients were randomly assigned in a 1:1 ratio to finerenone (10 or 20 mg daily, based on eGFR) or a matching placebo and were followed for 6 months. The primary outcome was the relative change in urinary albumin-to-creatinine ratio from baseline over the 6-month treatment period.1
Study Findings
Among participants assigned to finerenone, the median urinary albumin-to-creatinine ratio decreased from 574.6 at baseline to 373.5 at 6 months. In the placebo group, median values decreased from 506.4 to 475.6. The geometric mean percentage change from baseline over 6 months was −34% with finerenone (least-squares geometric mean ratio, 0.66; 95% CI, 0.60 to 0.73) and −12% with placebo (least-squares geometric mean ratio, 0.88; 95% CI, 0.79 to 0.98). This corresponded to a 25% greater reduction with finerenone than with placebo (geometric mean ratio, 0.75; 95% CI, 0.65 to 0.87; P < .001).1
At month 6, 54.3% of participants in the finerenone group achieved a reduction in urinary albumin-to-creatinine ratio of at least 30%, compared with 32.7% in the placebo group; reductions of at least 50% occurred in 28.4% and 21.8%, respectively. Adverse events occurred in 47.1% of participants receiving finerenone and 49.2% receiving placebo; serious adverse events were reported in 11.8% and 11.5%, respectively. Hyperkalemia was the most common adverse event, reported in 10.1% of the finerenone group and 3.3% of the placebo group; 1.7% discontinued finerenone because of hyperkalemia.1
The least-squares mean change in eGFR from baseline to month 6 was −5.6 mL/min/1.73 m² with finerenone and −2.7 mL/min/1.73 m² with placebo (difference, −2.9 mL/min/1.73 m²; 95% CI, −5.1 to −0.7). eGFR values in the finerenone group approached baseline during the 30-day washout period. Albuminuria increased after finerenone was stopped.1
Clinical Implications
According to the study authors, finerenone added to guideline-directed therapy resulted in a significantly greater reduction in albuminuria than placebo in adults with type 1 diabetes and CKD. The authors noted that finerenone was associated with more hyperkalemia events than placebo and an early decline in eGFR that partially reversed during washout, emphasizing that larger and longer studies are required to evaluate kidney-related effects, since the trial was not powered to determine effects on clinical kidney outcomes.1
In an accompanying editorial in The New England Journal of Medicine, Aleksandra Kukla, MD and Marie C. Hogan, MD, PhD, describe FINE-ONE as “an important step toward better treatments for kidney disease in patients with type 1 diabetes, particularly those with albuminuria,” but caution that “a larger, longer trial designed to show sustained kidney-function benefit with broader eligibility may be required before integration into practice can occur.”2 They also note that use of finerenone was associated with an early eGFR decline consistent with hemodynamic effects of renin–angiotensin–aldosterone system blockade and highlight the need to study patients with type 1 diabetes who have kidney-function decline without albuminuria, as well as evaluate additional therapies such as SGLT2 inhibitors.2
Expert Commentary
“In this trial involving adults with type 1 diabetes and CKD, finerenone resulted in a significantly greater decrease in the urinary albumin-to-creatinine ratio than placebo over 6 months of treatment,” the researchers concluded.1
References
- Heerspink HJL, Birkenfeld AL, Cherney DZI, et al; FINE-ONE Investigators. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957.
- Kukla A, Hogan MC. Finerenone for diabetic kidney disease in type 1 diabetes — a fine answer? N Engl J Med. 2026;394(10):1019-1020.