Finerenone Achieves 25 Percent Greater Albuminuria Reduction in Type 1 Diabetes and CKD: FINE-ONE Study Finds

While previous clinical research has established that finerenone improves both renal and cardiovascular outcomes for individuals with type 2 diabetes and chronic kidney disease (CKD), its specific efficacy and safety profile for patients with type 1 diabetes remained a significant clinical gap that Dr. Hiddo J.L. Heerspink from the University Medical Center Groningen and the FINE-ONE Investigators sought to address by evaluating the drug's impact on albuminuria in this distinct population.

Therefore, the Phase 3, randomized, double-blind trial enrolled 242 adults with type 1 diabetes and CKD—defined by an estimated glomerular filtration rate (eGFR) of 25 to <90 ml/min/1.73 m² and a urinary albumin-to-creatinine ratio (UACR) ranging from 200 to <5000—who were already receiving standard-of-care angiotensin-converting–enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) to compare the effects of daily finerenone against a matching placebo over a six-month duration. Participants were randomly assigned to either receive daily finerenone (10 or 20 mg based on kidney function) or a placebo to evaluate the primary endpoint of relative change in UACR, while excluding those with potassium levels outside safe ranges to maintain clinical safety during the intervention.

Key Clinical Findings of the Study Include:

• Superior Albuminuria Reduction: The FINE-ONE study demonstrated that finerenone treatment resulted in a 25% greater reduction in the UACR compared to the placebo group after six months (P<0.001).

• Robust Treatment Response: In the FINE-ONE trial, albuminuria decreased by 34% from baseline in those receiving finerenone, whereas those in the placebo group only experienced a 12% decline.

• Hyperkalemia Incidence: Clinicians should note that in the FINE-ONE study, hyperkalemia was the most frequent adverse event, occurring in 10.1% of the finerenone group versus 3.3% of those on placebo.

• Manageable Potassium Levels: Despite higher rates of elevated potassium, the FINE-ONE data indicated that only 1.7% of participants required permanent discontinuation of the therapy due to this side effect.

• Transient Renal Hemodynamics: The FINE-ONE investigation observed an initial decrease in eGFR of -5.6 ml/min/1.73 m² in the finerenone arm versus -2.7 ml/min/1.73 m² in the placebo arm, though kidney function values trended back toward baseline during the washout period.

The results suggest that finerenone provides a clinically meaningful decrease in albuminuria for adults with type 1 diabetes and CKD, as seen by the median UACR dropping from 574.6 to 373.5 in the treatment group compared to a minimal change from 506.4 to 475.6 in the control group

This study concludes that incorporating nonsteroidal mineralocorticoid receptor antagonists into the treatment regimen for type 1 diabetes patients could offer a new pathway for enhancing kidney protection.

While the current data are promising, the relatively short six-month duration and the observed initial dip in estimated glomerular filtration rate indicate that further long-term research is necessary to fully confirm the drug's enduring impact on renal health and its overall safety profile in this specific patient group.

Reference

Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med. 2026;394(10):947-957. doi: 10.1056/NEJMoa2512854.