Key result
Finerenone reduces major kidney events ~43% vs placebo in Chinese patients.
Why the study?
Although finerenone reduced heart and kidney outcomes in FIDELITY, its efficacy and safety specifically in Chinese patients required exploration.
Does finerenone reduce the risk of kidney and cardiovascular composite outcomes in Chinese patients with chronic kidney disease and type 2 diabetes?
RCT (n=697)
1:1
Yes
Does finerenone reduce the risk of kidney and cardiovascular composite outcomes in Chinese patients with chronic kidney disease and type 2 diabetes?
In Chinese patients with chronic kidney disease and type 2 diabetes, finerenone significantly reduces the risk of kidney composite outcomes with a manageable safety profile.
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Supports finerenone for kidney protection in Chinese CKD/T2D patients; extends FIDELITY efficacy to this subgroup.
Background Finerenone, a non-steroidal mineralocorticoid receptor antagonist, reduced the risk of heart and kidney outcomes in patients with chronic kidney disease and type 2 diabetes 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. Methods Patients with chronic kidney disease (urine albumin-to-creatinine ratio 30–5000 mg/g, estimated glomerular filtration rate [eGFR] ≥25 mL/min/1.73 m2) and type 2 diabetes, 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, non-fatal myocardial infarction, non-fatal 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. Results 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%). Conclusion Finerenone demonstrated kidney benefits, favorable trends on CV outcome, and a manageable safety profile in the FIDELITY Chinese subpopulation.
Li et al. (2026) conducted an RCT in Chronic kidney disease and type 2 diabetes (n=697). Finerenone vs. Placebo was evaluated on Kidney composite (kidney failure, sustained ≥57% eGFR decrease from baseline over ≥4 weeks, or kidney-related death) (HR 0.57, 95% CI 0.38-0.86, p=0.0066). Finerenone reduced the risk of the kidney composite outcome (kidney failure, ≥57% eGFR decrease, or kidney-related death) compared to placebo in Chinese patients (HR 0.57; 95% CI 0.38-0.86; p=0.0066).
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