FDA Approves Kerendia for CKD in Adults With Type 1 Diabetes

Bayer announced that the FDA has approved finerenone (Kerendia, Bayer) to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate decline and end-stage kidney disease in adults with chronic kidney disease (CKD) associated with type 1 diabetes. The decision followed Priority Review of a supplemental new drug application.

The approval was supported by the phase 3 FINE-ONE trial, along with phase 3 data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD associated with type 2 diabetes. FINE-ONE was a global, randomized, double-blind, placebo-controlled study involving 242 adults with CKD associated with type 1 diabetes. Participants received finerenone 10mg or 20mg once daily, or placebo, in addition to standard care for six months.

The primary objective was to determine whether finerenone was superior to placebo in reducing UACR, averaged over months 3 and 6. Finerenone significantly reduced UACR compared with placebo over six months (P=.0001). The relative reduction was 22% at month 3 (least-squares geometric mean ratio, 0.78; 95% CI, 0.68-0.90) and 28% at month 6 (ratio, 0.72; 95% CI, 0.60-0.86).

Treatment-emergent adverse events occurred in 47.1% of the finerenone group and 49.2% of the placebo group; serious adverse events occurred in 11.8% and 11.5%, respectively. Hyperkalemia was more frequent with finerenone than placebo (10.1% vs 3.3%), and discontinuation because of hyperkalemia occurred in 1.7% and 0%, respectively. The prescribing information warns that finerenone can cause hyperkalemia and lists concomitant strong CYP3A4 inhibitor use, adrenal insufficiency, and hypersensitivity to a product component as contraindications.

The FINE-ONE trial’s primary endpoint was UACR rather than a clinical kidney outcome. According to Bayer, the UACR findings supported bridging finerenone’s established kidney-outcome evidence from CKD associated with type 2 diabetes to patients with CKD associated with type 1 diabetes.

Source: 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. News release. Bayer; September 17, 2026. Accessed September 17, 2026.