FIDELIO DKD
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
70.4% male
N = 5734
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 hemoglobin 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
17.8
21.1
21.1 %
15.8 %
10.6 %
5.3 %
0.0 %
Finerenone
Placebo
Significant
decrease ▼
NNT = 30
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.
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