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NewsFinerenone (Kerendia) just got the FDA green light for chronic kidney disease in adults with type 1 diabetes — the first new treatment for this indication in more than three decades. The approval is based on phase 3 FINE-ONE trial data showing a 28% reduction in urinary albumin-to-creatinine ratio at 6 months. This fills a long-standing gap for a population with very limited options.
The FDA has approved finerenone (Kerendia, Bayer) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D) — marking the first new therapy approved for this indication in over 30 years. The once-daily oral nonsteroidal mineralocorticoid receptor antagonist is expected to slow CKD progression by reducing the risk of sustained eGFR decline and end-stage kidney disease.
The approval was supported by the phase 3 FINE-ONE trial (242 patients with CKD and T1D) alongside existing data from the FIDELIO-DKD and FIGARO-DKD trials in type 2 diabetes. Experts note the approval is especially significant given that SGLT2 inhibitors — another kidney-protective drug class — carry diabetic ketoacidosis risks that limit their use in T1D patients.
By the Numbers:
Why it matters: For the roughly 20–30% of T1D patients who also have CKD, treatment options have been stagnant for decades. Finerenone's approval offers clinicians a meaningful new tool to slow kidney disease progression in this underserved population, particularly where other drug classes fall short.