Efficacy of febuxostat for slowing the GFR decline in patients with CKD and asymptomatic hyperuricemia: A 6-month, double-blind, randomized, placebo-controlled trial

Abstract

Background Hyperuricemia is a putative risk factor for the progression of chronic kidney disease (CKD). We hypothesized that control of asymptomatic hyperuricemia may slow disease progression in CKD. Study Design This was a single-center, double-blind, randomized, parallel-group, placebo-controlled study. Setting & Participants Eligible participants were adults from Eastern India aged 18 to 65 years with CKD stages 3 and 4, with asymptomatic hyperuricemia. Intervention The intervention group received febuxostat, 40 mg, once daily for 6 months, while the placebo group received placebo; both groups were followed up for 6 months. Outcomes The primary outcome was the proportion of patients showing a >10% decline in estimated glomerular filtration rate (eGFR) from baseline in the febuxostat and placebo groups. Secondary outcomes included changes in eGFRs in the 2 groups from baseline and at the end of the study period. Results 45 patients in the febuxostat group and 48 in the placebo group were analyzed. Mean eGFR in the febuxostat group showed a nonsignificant increase from 31.5 ± 13.6 (SD) to 34.7 ± 18.1 mL/min/1.73 m2 at 6 months. With placebo, mean eGFR decreased from a baseline of 32.6 ± 11.6 to 28.2 ± 11.5 mL/min/1.73 m2 (P = 0.003). The difference between groups was 6.5 (95% CI, 0.08-12.81) mL/min/1.73 m2 at 6 months (P = 0.05). 17 of 45 (38%) participants in the febuxostat group had a >10% decline in eGFR over baseline compared with 26 of 48 (54%) from the placebo group (P < 0.004). Limitations Limitations of this study included small numbers of patients and short follow-up, and ∼10% of the randomly assigned population dropped out prior to completion. Conclusions Febuxostat slowed the decline in eGFR in CKD stages 3 and 4 compared to placebo.