ArticleAmerican journal of nephrology2026
Effect of Finerenone Treatment Discontinuation on Kidney and Cardiovascular Outcomes: A Fidelity Analysis.
Article in American journal of nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
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12 authors.
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Abstract
introductionFinerenone reduced the risk of heart and kidney events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis combining data from the phase III FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) trials. This FIDELITY analysis aimed to identify and assess key predictors of finerenone discontinuation and evaluate the impact of discontinuation on its efficacy in people with CKD and T2D.
methodsAdults 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 inhibition were randomized 1:1 to finerenone or placebo. Baseline characteristics were identified and assessed as predictors of treatment discontinuation using a multivariate Cox proportional hazards model. Stratified Cox models with treatment discontinuation as a time-varying covariate were used to assess the effect of treatment discontinuation on composite kidney and cardiovascular (CV) outcomes (kidney: kidney failure, sustained ≥57% eGFR decrease from baseline over at least 4 weeks, or kidney-related death; CV: CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure).
resultsAmong 12,990 participants included in the analysis, 22.8% and 21.6% prematurely discontinued treatment in the finerenone and placebo arms, respectively. Advanced age, White/Black race, lower eGFR, higher urine albumin-to-creatinine ratio, and higher serum potassium at baseline were identified as predictors of finerenone discontinuation. Crude event rates per 100 patient-years for the composite kidney and CV outcomes were lower with finerenone versus placebo under treatment (kidney: 1.09 vs. 1.71; CV: 2.98 vs. 3.78) as well as after discontinuation (kidney: 11.95 vs. 13.67; CV: 14.07 vs. 14.73). The effect of finerenone on composite kidney and CV outcomes appeared to be reduced after discontinuation (hazard ratio [HR] = 0.82; 95% confidence interval [CI] 0.66-1.02; HR = 0.93; 95% CI: 0.79-1.09, respectively) versus the time on-treatment (HR = 0.65; 95% CI: 0.54-0.78; p
conclusionIn FIDELITY, treatment discontinuation rates were similar in the finerenone and placebo arms. Finerenone demonstrated numerically higher kidney and CV benefits during treatment versus after discontinuation.
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