Objectives: The efficacy and safety of febuxostat in patients with stage 4-5 chronic kidney disease (CKD) remain unclear, although it is commonly used in clinical practice. Clinical trials are lacking due to ethical issues related to the enrollment of advanced CKD patients. We aimed to evaluate the efficacy and safety of febuxostat in patients with stage 4-5 CKD not yet on dialysis through a meta-analysis of observational studies. Methods: We performed a systematic search in PubMed, Ovid MEDLINE, Embase, and the Cochrane Library to find observational studies on cohorts of advanced CKD patients starting febuxostat. Articles describing changes from baseline in serum urate levels and renal function assessed by estimated the glomerular filtration rate (eGFR) were included. The articles were screened by two independent reviewers (YP and HJ). We performed a meta-analysis using a random-effects model and used R software with the ‘meta’ and ‘Rcpp’ packages for statistical analyses. Results: Among 148 retrieved studies, five relevant observational studies involving 327 patients were included in the meta-analysis. Daily febuxostat doses of 10-120 mg were administered treatment periods of 3-12 months. The urate-lowering effect after febuxostat use was statistically significant (weighted mean difference, -1.85; 95% CI, -2.04 to -1.67; I2; 0%, Figure 1A). Three studies involving 145 patients included eGFR assessments. Renal function as assessed by eGFR did not decrease after febuxostat use (weighted mean difference, 0.11; 95% CI, -0.25 to 0.47; I2; 45%, Figure 1B). Conclusions: Febuxostat has acceptable urate-lowering efficacy and renal safety in hyperuricemia patients with stage 4-5 CKD who are not yet on dialysis.