Efficacy of Febuxostat for Slowing the GFR Decline in Patients With CKD and Asymptomatic Hyperuricemia: A 6-Month, Double-Blind, Randomized, Placebo-Controlled Trial

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 +/- 6 18.1 mL/min/1.73 m(2) 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 m(2) (P = 0.003). The difference between groups was 6.5 (95% CI, 0.08-12.81) mL/min/1.73 m(2) 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 similar to 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. (C) 2015 by the National Kidney Foundation, Inc.