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 m 2 ) than in patients without (58 ± 22 mL/min/1.73 m 2 ). 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.