6/28/23, 10:35 PM FIDELIO DKD Pathway Feedback Search Clinical Topics Home Studies FIDELIO DKD FIDELIO DKD Disease Disease Chronic kidney disease Diabetes mellitus type 2 Trial question What is the long-term effect of finerenone on CKD outcomes in T2DM patients? Study design Multi-center Double blinded RCT Population Characteristics of study participants 29.6% female N = 5734 70.4% male 5734 patients (1691 female, 3983 male) Inclusion criteria: patients with CKD and T2DM Key exclusion criteria: confirmed significant non-diabetic renal disease, uncontrolled arterial hypertension, chronic HFrEF, dialysis for acute renal failure within 12 weeks of run-in visit, renal allograft in place, scheduled kidney transplant within next 12 months, or glycated Hgb HbA1c > 12% Interventions N=2833 finerenone (10 mg or 20 mg PO once daily) N=2841 placebo (matching placebo tablet PO once daily) Primary outcome Kidney failure, sustained decline of at least 40% in eGFR from baseline, or death from renal causes 21.1 21.1 % 17.8 https://web.pathway.md/studies/recjZZkd3LcsVzSze 1/2 6/28/23, 10:35 PM FIDELIO DKD Pathway 15.8 % 10.6 % Significant decrease 5.3 % NNT = 30 0.0 % Finerenone Placebo Significant decrease in kidney failure, sustained decline of at least 40% in the eGFR from baseline, or death from renal causes (17.8% vs. 21.1%; HR 0.82, 95% CI 0.73 to 0.93) Secondary outcomes Significant decrease in death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for HF (13% vs. 14.8%; HR 0.86, 95% CI 0.75 to 0.99) No significant difference in death from any cause (7.7% vs. 8.6%; HR 0.9, 95% CI 0.75 to 1.07) No significant difference in hospitalization for any cause (44.6% vs. 46.5%; HR 0.95, 95% CI 0.88 to 1.02) Safety outcomes No significant difference in adverse events or AKI. Significant differences in serious adverse events (31.9% vs. 34.3%), hyperkalemia-related adverse events (18.3% vs. 9.0%), incidence of hyperkalemia-related discontinuation (2.3% vs. 0.9%). Conclusion In patients with CKD and T2DM, finerenone was superior to placebo with respect to kidney failure, sustained decline of at least 40% in the eGFR from baseline, or death from renal causes. Reference George L Bakris, Rajiv Agarwal, Stefan D Anker et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. Open reference URL https://web.pathway.md/studies/recjZZkd3LcsVzSze 2/2