Abstract
Background/Objectives: To evaluate the efficacy and safety of finerenone compared to placebo in improving renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Methods: A systematic review and meta-analysis were conducted, compiling RCTs evaluated the effect of finerenone compared to placebo in patients with CKD and T2D. Inclusion criteria included adults with CKD and T2D. Outcomes included kidney failure, end-stage renal disease (ESKD), and persistently decreased glomerular filtration rate (eGFR). Secondary outcomes included cardiovascular events, hospitalization due to hyperkalemia, and serious adverse events. Pooled relative risks (RRs) and mean differences (MDs) were calculated using a random-effects model. Results: Three RCTs with a total of 19,027 patients were included. Finerenone demonstrated a potential reduction in kidney failure risk (RR 0.86, 95% CI: 0.35-2.13) and ESKD (RR 0.82, 95% CI: 0.54-1.23); however, confidence intervals included the null effect. There were no statistically significant differences, as seen in the decrease in eGFR (RR 1.03; 95% CI: 0.27-3.85), but also in mortality due to renal causes (RR 0.62; 95% CI: 0.00-7168.81). Finerenone increased hyperkalemia-related hospitalizations (RR 4.57, 95% CI: 1.07-19.48) but had no significant effect on serious adverse events (RR 0.94, 95% CI: 0.92-0.97) or systolic BP (MD 0.08 mmHg, 95% CI: -0.36 to 0.52). Conclusions: Finerenone may provide renal protection in CKD and T2D, though benefits remain uncertain due to wide confidence intervals and study heterogeneity. The increased risk of hyperkalemia warrants careful patient selection and monitoring. Further research is needed to refine its clinical applicability. Review registration: PROSPERO CRD420250642593.