FDA Approves Finerenone for Chronic Kidney Disease Associated with Type 1 Diabetes

The FDA has approved finerenone (KERENDIA) for adults with chronic kidney disease associated with type 1 diabetes, opening a new treatment option for a patient population that has gone more than three decades without a proven therapeutic advance specifically addressing CKD progression.

The approval allows the non-steroidal mineralocorticoid receptor antagonist to be used to reduce urinary albumin-to-creatinine ratio (UACR), a change expected to reduce the risk of sustained estimated glomerular filtration rate decline and end-stage kidney disease. The decision followed Priority Review of Bayer’s supplemental New Drug Application.

The distinction is important: the new indication is based on reducing UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with type 1 diabetes. UACR is an important marker of CKD progression, and evidence from finerenone’s clinical program in patients with CKD and type 2 diabetes has linked reductions in UACR with improved kidney outcomes.

That evidence provided a bridge to the Phase III FINE-ONE trial, which evaluated finerenone specifically in adults with CKD associated with type 1 diabetes. FINE-ONE was a global, randomized, prospective, double-blind, placebo-controlled Phase III study involving 242 adults with CKD associated with type 1 diabetes. Participants received finerenone at 10 mg or 20 mg once daily or placebo in addition to standard care. The primary objective was to determine whether finerenone was superior to placebo in reducing UACR over six months, averaged across measurements at months 3 and 6.

Finerenone significantly reduced UACR compared with placebo over six months, with a reported P value of 0.0001. The effect emerged by month 3, when UACR was reduced by 22% relative to placebo, corresponding to a least-square geometric mean ratio of 0.78 (95% CI, 0.68-0.90). By month 6, the reduction relative to placebo reached 28%, with a ratio of 0.72 (95% CI, 0.60-0.86).

Safety and tolerability were consistent with existing evidence for finerenone in adults with CKD associated with type 2 diabetes. Treatment-emergent adverse events occurred in 47.1% of patients receiving finerenone and 49.2% receiving placebo, while serious treatment-emergent adverse events occurred in 11.8% and 11.5%, respectively.

Hyperkalemia remains a clinically important consideration. In FINE-ONE, it occurred in 10.1% of patients receiving finerenone compared with 3.3% receiving placebo. Treatment discontinuation because of hyperkalemia occurred in 1.7% of the finerenone group and no placebo recipients.

The prescribing information calls for serum potassium and eGFR measurement before starting therapy and subsequent potassium monitoring during treatment. Finerenone should not be initiated when serum potassium exceeds 5 mEq/L. The drug is also contraindicated in patients receiving strong CYP3A4 inhibitors, those with adrenal insufficiency, and patients with hypersensitivity to a component of the product.

For clinicians, the approval expands the reach of a drug already used across kidney and cardiovascular disease. Finerenone has been FDA approved since 2021 to reduce kidney and cardiovascular risks in adults with CKD associated with type 2 diabetes. In July 2025, it gained an additional indication to reduce cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure and a left ventricular ejection fraction of at least 40%.

The latest decision makes once-daily oral finerenone the only mineralocorticoid receptor antagonist indicated for adults with CKD associated with either type 1 or type 2 diabetes.

For adults with CKD associated with type 1 diabetes, the approval introduces another treatment option for addressing kidney risk—one that requires attention to potassium levels, kidney function, concomitant medications, and the precise evidence behind the indication. FINE-ONE demonstrated a significant effect on UACR; the anticipated reduction in longer-term kidney outcomes is supported by the relationship between albuminuria reduction and kidney outcomes established in finerenone’s type 2 diabetes clinical program.

Detailed results from FINE-ONE were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine. With the FDA decision, those findings have now translated into the first new approved treatment in more than 30 years for adults with CKD associated with type 1 diabetes.