Finerenone Approval Expands CKD Care in Type 1 Diabetes

Chronic kidney disease (CKD) in type 1 diabetes now has its first new FDA-approved therapy in roughly 30 years, with finerenone (Kerendia) gaining an indication built on dedicated trial data rather than extrapolation.¹

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the approval of the nonsteroidal mineralocorticoid receptor antagonist (MRA) and the phase 3 FINE-ONE trial behind it.

Watch the full episode discussing finerenone’s new approval here.

Evidence gaps have long shaped care in type 1 diabetes. Because far more people live with type 2 diabetes, trials and indications have concentrated there, including finerenone's prior approvals for CKD in type 2 diabetes and for heart failure. Without dedicated data, clinicians could not confirm benefit in type 1 diabetes, and coverage often proved difficult.

FINE-ONE randomized 242 adults across 80 sites in nine countries to finerenone or placebo, each added to standard of care, in a double-blind design. Finerenone reduced the urine albumin-to-creatinine ratio (UACR) by 25% relative to placebo over six months. At any point after baseline, 68.1% of finerenone recipients achieved a UACR reduction of at least 30%, compared with 46.6% of placebo recipients.

The 30% threshold carries clinical weight, as the American Diabetes Association recognizes it as a marker of slower CKD progression. Hyperkalemia occurred more often with finerenone than placebo (10.1% vs 3.3%) and led to discontinuation in 1.7% of patients, reinforcing the need for routine potassium monitoring.

The approval also fills a gap left by sodium-glucose cotransporter 2 (SGLT2) inhibitors. Trials of the class in type 1 diabetes did not use kidney endpoints, and the risk of euglycemic diabetic ketoacidosis, a real concern in practice, has kept these agents from FDA approval in this population.

Finerenone adds to, rather than replaces, control of blood pressure, lipids, and glycemia, each of which drives injury in the small renal arterioles. Its benefit depends on detecting albuminuria, yet annual UACR screening remains underused. Explaining to patients that the urine test looks only for protein, not drug use, can improve participation.

Collectively, the approval gives clinicians a kidney-protective option with dedicated evidence in type 1 diabetes and places renewed emphasis on routine albuminuria screening as the entry point to treatment.

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