Finerenone Shows Benefits for Chronic Kidney Disease for Patients With Type 1 Diabetes

Finerenone (Kerendia) significantly reduced urine albumin-to-creatinine ratio (UACR) by 25% from baseline to 6 months compared with the placebo for patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who received the standard of care. In 2021, finerenone was approved to reduce the risk of cardiovascular death, hospitalization for heart failure, nonfatal myocardial infarction, sustained estimated glomerular filtration rate decline, and end-stage kidney disease for patients with CKD associated with type 2 diabetes.¹

“We are excited to announce the results of the FINE-ONE trial, which represents the first positive phase III study in 30 years for patients with type 1 diabetes and chronic kidney disease—a research advancement underscored by the trial’s inclusion in the opening plenary session,” Janet McGill, professor of medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine, said in a news release.¹ “By significantly reducing UACR—a key marker of cardiovascular risk and kidney damage—finerenone has the potential to become an important addition to the treatment landscape for patients with type 1 diabetes and chronic kidney disease.”

According to the American Diabetes Association, T1D has been associated with a decline in kidney function. Standard of care has reduced the incidence of fast-progressing kidney disease; the authors noted that the interventions have not slowed kidney decline in most patients. This shows a need to develop approaches that focus on T1D and provide early kidney protection, which is as important as glucose control.²

In the study, investigators aimed to determine if finerenone could slow patients’ kidney disease from getting worse when added to the standard of care. Further, they wanted to determine the safety of the drug, such as treatment-emergent adverse events (TEAEs), serious TEAEs, and hyperkalemia. Patients received the study treatment for 6 months, and investigators collected blood and urine samples, checked vital signs, conducted a physical examination, and used an electrocardiogram test. The primary end point included change in UACR from baseline to 6 months, and secondary end points included the number of patients with TEAEs and serious TEAEs as well as the number of participants with hyperkalemia.³

There were 242 patients that were enrolled for the primary outcome, with investigators finding that the safety and tolerability of finerenone were consistent with the existing evidence for patients with CKD and T2D. The rate of TEAEs was 47.1% for those treated with the study drug and 49.2% for the placebo. For serious AEs, approximately 11.8% and 11.5% of patients experienced them, respectively, and approximately 10.1% and 3.3% of patients experienced hyperkalemia, respectively.¹

“FINE-ONE is the fourth positive consecutive pivotal phase 3 clinical trial for Kerendia,” Carolina Aldworth, MD, MSc, executive medical director at Bayer, said in a news release.¹ “The findings represent another important milestone, reinforcing the evidence for Kerendia across cardiovascular and kidney care in multiple patient populations.”

Bayer will submit a supplemental new drug application to the FDA based on the results in 2026.¹

READ MORE: Diabetes Resource Center

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REFERENCES

1. Kerendia (finerenone) meets primary endpoint in phase 3 clinical trial for adults with type 1 diabetes and chronic kidney disease. News release. Bayer. November 6, 2025. Accessed November 6, 2025. https://www.bayer.com/en/us/news-stories/kerendia-for-type-1-diabetes-and-chronic-kidney-disease

2. Thomas MC, Zoungas S, Hanssen NMJ, McAuley SA, Cooper ME. Kidney Disease: The Forgotten Legacy of Type 1 Diabetes. Diabetes Care. 2025;48(8):1299-1308. doi:10.2337/dci25-0028

3. A study to learn how well the study treatment finerenone works and how safe it is in people with long-term decrease in the kidneys’ ability to work properly (chronic kidney disease) together with type 1 diabetes (FINE-ONE). ClinicalTrials.gov identification: October 21, 2025. Accessed November 6, 2025. https://clinicaltrials.gov/study/NCT05901831