Abstract
Introduction and Objective: CKD occurs in 1 of 3 people with T1D, with substantial loss of kidney function in over half and kidney failure in nearly one fourth. Therapies to reduce these outcomes in T1D are urgently needed. The nonsteroidal mineralocorticoid receptor antagonist finerenone, on top of ACEi/ARB, reduced the risk of kidney and heart outcomes in people with CKD and T2D. The FINE-ONE trial (NCT05901831) will assess the efficacy and safety of finerenone in people with T1D and CKD. Methods: FINE-ONE is an ongoing, global, phase III trial with finerenone. Participants (n=220) with T1D and CKD (UACR ≥200-<5000 mg/g and eGFR ≥25-<90 mL/min/1.73 m2), HbA1c <10%, and serum potassium ≤4.8 mmol/L, on a stable dose of ACEi/ARB, will be randomized 1:1 to finerenone (10 or 20 mg od) or placebo. The primary efficacy outcome is the relative change in UACR from baseline over 6 months (trial duration~7.5 months). Results: At baseline, 176 randomized participants with T1D had mean HbA1c of 7.6%, mean eGFR of 60 mL/min/1.73 m2, median UACR of 536 mg/g, mean age of 51 years, and 38% were female (Table). A high proportion had a history of hypertension (82%) and 21% had CVD. The most common race was White (71%), followed by Asian (19%) and Black (7%). Conclusion: FINE-ONE will determine the efficacy and safety of finerenone in a representative population with T1D and CKD at high risk of progressive kidney function loss.