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Jump to Key Points The FDA has approved finerenone (Kerendia, Bayer) for the treatment of adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D).
The once-daily oral nonsteroidal mineralocorticoid receptor agonist reduces the urinary albumin-to-creatinine ratio (UACR), which is expected to lower the risk for sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with CKD and T1D. It is the first new treatment for CKD in adults with T1D in more than 30 years, according to a statement from Bayer.
Approximately 20%-30% of people in the US with T1D also have CKD, the company noted.
The approval was based on data from the phase 3 FINE-ONE clinical trial in 242 adults with CKD associated with T1D, showing a 22% decline in UACR compared with placebo by 3 months, and a 28% reduction by 6 months. The FDA approval decision was also informed by phase 3 data in two trials in adults with type 2 diabetes and CKD, FIDELIO-DKD and FIGARO-DKD.
- FDA approved finerenone for CKD in adults with T1D.
- First new CKD therapy for T1D in >30 years.
- FINE-ONE: UACR ↓ 22% at 3 months; 28% at 6 months.
- Approval informed by FIDELIO-DKD and FIGARO-DKD T2D CKD data.
- Serum potassium monitoring is essential; SGLT2i use in T1D limited by DKA concerns.
Commenting for Medscape about FINE-ONE in July 2026, Anne L. Peters, MD, who does not have relevant financial ties with Bayer, wrote “Overall, I think this study shows us that finerenone works in patients with type 1 diabetes, just as it works in patients with type 2 diabetes. We don’t have the long-term cardiovascular outcome data that we have in type 2 diabetes or data that look at eGFR over time, but I think it’s a great proof of concept that this drug works similarly in both types of diabetes, and I think it’s a drug we can use with some confidence in our patients with type 1 diabetes.”
Added Peters, professor of clinical medicine, Department of Endocrinology/Internal Medicine, University of Southern California, Los Angeles, “The obvious thing to watch is the serum potassium level, as one would do with anybody on this drug. I think it adds to what we can do in our patients with type 1 diabetes, particularly because of the concerns about diabetic ketoacidosis with SGLT2 inhibitors, which may limit our use of that medication to help renal function in patients with type 1 diabetes and CKD.”
Finerenone is also licensed in the US for reducing the risk for sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes. It also is indicated for reduction of the risk for CV death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction of 40% or greater.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social
