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NewsThe FDA has approved finerenone (Kerendia) for adults with chronic kidney disease (CKD) associated with type 1 diabetes — the first new treatment for this indication in more than 30 years. The once-daily oral pill reduces urinary albumin-to-creatinine ratio (UACR), a key marker of kidney damage, and is expected to slow CKD progression. Approval was based on the phase 3 FINE-ONE trial, which showed significant UACR reductions compared to placebo.
The FDA has approved finerenone (Kerendia, Bayer) for adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), marking the first new treatment for this indication in over 30 years. The once-daily oral nonsteroidal mineralocorticoid receptor antagonist works by reducing urinary albumin-to-creatinine ratio (UACR), which is expected to slow CKD progression and lower the risk of end-stage kidney disease. Roughly 20–30% of Americans with T1D also have CKD, representing a population with long-standing unmet medical need.
The approval was primarily based on the phase 3 FINE-ONE trial in 242 adults with CKD and T1D, and was further supported by existing data from the FIDELIO-DKD and FIGARO-DKD trials in type 2 diabetes. Finerenone was previously approved for CKD in type 2 diabetes (2021) and heart failure with preserved or mildly reduced ejection fraction (2025).
By the Numbers:
Why it matters: For T1D patients with CKD, treatment options have been stagnant for decades. SGLT2 inhibitors — a go-to for kidney protection in type 2 diabetes — carry diabetic ketoacidosis risks in T1D, limiting their use. Finerenone now fills a critical gap, giving clinicians a new, evidence-backed tool to slow kidney disease progression in this underserved population.