Finerenone in People with Chronic Kidney Disease, Type 2 Diabetes, and History of Nephrectomy

BACKGROUND: Finerenone significantly reduced the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis of two phase 3 trials. This post hoc FIDELITY analysis examined the efficacy and safety of finerenone in patients with CKD, T2D, and a history of nephrectomy.

METHODS: Patients in FIDELITY were randomized to receive finerenone or placebo and were on optimized renin-angiotensin system inhibition. We identified nephrectomy status using patients' medical history and assessed CKD progression in patients by nephrectomy status at baseline by modeling change in urine albumin-to-creatinine ratio (UACR) from baseline to months 4-24. Safety outcomes included treatment-emergent adverse events (TEAEs) and incident hyperkalemia.

RESULTS: Of 12,990 patients, 108 had a history of nephrectomy at baseline; 101/108 had radical nephrectomy, 55 received finerenone, and 53 received placebo. Baseline mean estimated glomerular filtration rates were numerically lower in patients with a history of nephrectomy (48 ± 17 mL/min/1.73 m2) than in patients without (58 ± 22 mL/min/1.73 m2). For patients with a history of nephrectomy, those who received finerenone had a greater UACR reduction at 4 months versus those who received placebo (least-squares mean ratio to baseline, 0.65 versus 1.09; least-squares mean treatment ratio, 0.60; 95% CI, 0.48-0.76; P<0.001). This reduction was maintained for two years. TEAEs were similar in patients with and without a history of nephrectomy. Among patients with a history of nephrectomy, treatment-emergent hyperkalemia occurred in 7% and 6% of finerenone and placebo groups, respectively.

CONCLUSIONS: Finerenone reduced albuminuria compared with placebo and demonstrated a safety profile consistent with the overall FIDELITY population in patients with and without a history of nephrectomy at baseline. Finerenone may delay CKD progression and associated morbidity in patients with CKD and T2D, irrespective of nephrectomy status.