Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY

In FIDELITY, finerenone improved kidney and cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines categorise CKD progression risk based on estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). This FIDELITY post hoc subanalysis investigated KDIGO risk category changes associated with finerenone. Improvement or worsening in KDIGO risk category was defined by variation from baseline, with specified eGFR and UACR changes. Association of these category changes with a CV composite outcome was assessed. Finerenone therapy led to a higher likelihood of KDIGO risk category improvement (odds ratio [OR], month 36: 1.47; 95% confidence interval [CI], 1.31–1.65; p < 0.0001) and lower likelihood of worsening (OR, month 36: 0.83; 95% CI, 0.77–0.90; p < 0.0001) vs. placebo. Risk category improvement reduced the CV composite outcome risk (hazard ratio [HR]: 0.82; 95% CI, 0.68–0.99; p = 0.043) while worsening increased this risk (HR: 1.29; 95% CI, 1.06–1.56; p = 0.01). Finerenone therapy is associated with greater improvement and less worsening in KDIGO risk vs. placebo. The category changes are associated with lower risk of CV events in patients with CKD and T2D. FIDELIO-DKD ( NCT02540993 ) and FIGARO-DKD ( NCT02545049 ) are registered with ClinicalTrials.gov (funded by Bayer AG). CI, confidence interval; CKD, chronic kidney disease; CV, cardiovascular; GFR, glomerular filtration rate; HHF, hospitalisation for heart failure; HR, hazard ratio; KDIGO, Kidney Disease: Improving Global Outcomes; od, once a day; R, randomised; T2D, type 2 diabetes. • Finerenone's effect on KDIGO risk categories was explored in a FIDELITY subanalysis. • Finerenone use led to higher odds of KDIGO risk category improvement than placebo. • Use of finerenone led to lower odds of KDIGO risk category worsening than placebo. • Improving KDIGO risk category (vs. worsening) led to lower risk of CV outcomes.