Table 2.
Summary of phase 3 clinical trials evaluating the safety and efficacy of finerenone on kidney failure and cardiovascular outcomes in patients with type 2 diabetes and chronic kidney disease
| Parameter | FIDELIO-DKD36 | FIGARO-DKD37 | FIDELITY35 (pooled analysis) |
|---|---|---|---|
| Year | 2020 | 2021 | 2022 |
| Patient population | T2DM and predominantly advanced CKD with severely increased albuminuria | T2DM and stage 2–4 CKD with moderately increased albuminuria or stage 1–2 CKD with severely increased albuminuria | T2DM and a broad spectrum of CKD |
| N | 5,674 | 7,352 | 13,026 |
| Intervention | Finerenone (10–20 mg/day) vs. placebo | Finerenone (10–20 mg/day) vs. placebo | Finerenone (10–20 mg/day) vs. placebo |
| Median follow-up (years) | 2.6 | 3.4 | 3.0 |
| Age (years) | 65.6 ± 9.1 | 64.1 ± 9.8 | 64.8 ± 9.5 |
| Male gender (n, %) | 3,983 (70.2%) | 5,105 (69.4%) | 9,088 (69.8%) |
| BMI (kg/m2) | 31.1 ± 6.0 | 31.4 ± 6.0 | 31.3 ± 6.0 |
| HbA1c (%) | 7.7 ± 1.3 | 7.7 ± 1.4 | 7.7 ± 1.4 |
| Serum potassium (mEq/l) | 4.4 ± 0.5 | 4.3 ± 0.4 | 4.35 ± 0.4 |
| eGFR (ml/min/1.73 m2) | 44.3 ± 12.6 | 67.8 ± 21.7 | 57.6 ± 21.7 |
| eGFR categories (n, %) | |||
| ≥60 ml/min/1.73 m2 | 656 (11.6%) | 4,539 (61.7%) | 5,195 (39.9%) |
| ≥45 to <60 ml/min/1.73 m2 | 1,900 (33.5%) | 1,534 (20.9%) | 3,434 (26.4%) |
| ≥25 to <45 ml/min/1.73 m2 | 2,981 (52.5%) | 1,251 (17.0%) | 4,232 (32.5%) |
| <25 ml/min/1.73 m2 | 135 (2.4%) | 27 (0.4%) | 162 (1.2%) |
| Median UACR (mg/g) | 852 (446–1,634) | 308 (108–740) | 515 (198–1,147) |
| UACR categories (n, %) | |||
| <30 mg/g | 23 (0.4%) | 207 (2.8%) | 230 (1.8%) |
| 30–300 mg/g | 685 (12.1%) | 3,414 (46.4%) | 4,099 (31.5%) |
| ≥300 mg/g | 4,963 (87.5%) | 3729 (50.7%) | 8,692 (66.7%) |
| ACEI/ARB use (n,%) | 5,667 (99.8%) | 7,343 (99.9%) | 13,003 (99.8%) |
| HR and 95% CI for key composite endpoints | |||
| Sustained ≥40% decrease in eGFR, kidney failure, or death from renal causes | 0.82 (0.73–0.93) | 0.87 (0.76–1.01) | 0.85 (0.77–0.93) |
| Sustained ≥57% decrease in eGFR, kidney failure, or death from renal causes | 0.76 (0.65–0.90) | 0.77 (0.60–0.99) | 0.77 (0.67–0.88) |
| Nonfatal MI, nonfatal stroke, hospitalization for HF, or cardiovascular death | 0.86 (0.75–0.99) | 0.87 (0.76–0.98) | 0.86 (0.78–0.95) |
Abbreviations: ACEI, angiotensin-converting-enzyme-inhibitor; ARB, angiotensin-receptor-blocker; BMI, body mass index; CI, confidence interval; CKD, chronic kidney disease; eGFR, estimated-glomerular-filtration-rate; HbA1c, glycated hemoglobin A1c; HF, heart failure; HR, hazard ratio; MI, myocardial infarction; T2DM, diabetes mellitus type 2; UACR, urinary albumin-to-creatinine ratio.