Diabetes Dialogue: Finerenone Approved for CKD in Type 1 Diabetes

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Chronic kidney disease remains a persistent risk for people with type 1 diabetes, with roughly 30% of this population in the US developing the complication despite optimized glucose, blood pressure, and lipid management. Until now, no therapy directly targeted the mineralocorticoid receptor pathway implicated in this progression for this group.1

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the US Food and Drug Administration (FDA)’s approval of finerenone (Kerendia) for chronic kidney disease associated with type 1 diabetes.

The approval marks the first new therapy in 30 years for this population and represents the third indication for finerenone, following its approvals for chronic kidney disease with type 2 diabetes in 2025 and for heart failure with left ventricular ejection fraction above 40%. Regulators granted priority review, and the decision draws on a broader evidence base spanning roughly 20,000 patients across five pivotal phase 3 trials of the nonsteroidal mineralocorticoid receptor antagonist class.

The phase 3 FINE-ONE trial, a randomized, placebo-controlled, double-blind study, enrolled 242 adults with type 1 diabetes across nine countries and 80 sites and supported the approval. Finerenone added to standard of care reduced urine albumin-to-creatinine ratio (UACR) by 25% from baseline over six months compared with placebo. Overall, 68.1% of participants receiving finerenone achieved a UACR reduction of at least 30%, versus 46.6% with placebo, a threshold the American Diabetes Association associates with slowed CKD progression.

Finerenone carries a risk of hyperkalemia, requiring potassium monitoring, and should not be combined with steroidal mineralocorticoid receptor antagonists such as spironolactone or with concurrent ACE inhibitor and angiotensin receptor blocker therapy. Unlike SGLT2 inhibitors, which remain unapproved in type 1 diabetes due to concerns about euglycemic diabetic ketoacidosis, finerenone offers clinicians a mechanistically distinct option with a defined safety profile in this population.

The approval also renews attention on UACR screening, which remains underused in primary care despite annual screening recommendations for all patients with diabetes. Broader adoption of routine screening, paired with earlier mineralocorticoid receptor antagonist initiation, may extend the renoprotective gains demonstrated in FINE-ONE to more patients with type 1 diabetes.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

References

1. Bayer. Bayer’s KERENDIA (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes. September 17, 2026. Accessed September 18, 2026. https://www.bayer.com/en/us/news-stories/treatment-forchronic-kidney-disease-and-type-1-diabetes