Finerenone in Chinese Patients with Chronic Kidney Disease and Type 2 Diabetes: A FIDELITY Subgroup Analysis

Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduced the risk of heart and kidney outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials. This subanalysis explored the efficacy and safety of finerenone vs. placebo in Chinese patients.

Patients with CKD (urine albumin-to-creatinine ratio 30-5,000 mg/g, estimated glomerular filtration rate [eGFR] ≥25 mL/min/1.73 m²) and T2D, on optimized renin-angiotensin system inhibitors, were randomized 1:1 to finerenone or placebo. Key outcomes included a kidney composite (kidney failure, sustained ≥57% eGFR decrease from baseline over ≥4 weeks, or kidney-related death) and a cardiovascular (CV) composite (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure). An additional kidney composite outcome was kidney failure, sustained ≥40% eGFR decrease from baseline over ≥4 weeks, or kidney-related death. Treatment-emergent adverse events were also assessed.

In this Chinese patient subanalysis (n = 697), finerenone reduced the risk of the ≥57% and ≥40% kidney composite outcomes (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.38-0.86; p = 0.0066 and HR: 0.54; 95% CI: 0.40-0.74; p < 0.0001, respectively) and CV composite outcome risk vs. placebo (HR: 0.82; 95% CI: 0.52-1.29; p = 0.3866). Safety outcomes were similar between treatment arms. Hyperkalemia leading to treatment discontinuation was low for finerenone (2.6%) and placebo (0.9%).

Finerenone demonstrated kidney benefits, favorable trends on CV outcome, and a manageable safety profile in the FIDELITY Chinese subpopulation.