The Effects of Allopurinol on the Progression of CKD According to Baseline Serum Urate Level: Results from Post Hoc Analyses of the CKD-FIX Trial

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Background: Allopurinol did not slow decline in estimated glomerular filtration rate (eGFR) over 2 years in patients with chronic kidney disease (CKD) at risk of progression in the CKD-FIX trial. We assessed the effect of allopurinol on eGFR slope by baseline serum urate level. Methods: In this trial, 369 adults with stage 3 or 4 CKD, without history of gout, and either urinary albumin-to-creatinine ratio ≥265 mg/g or eGFR decrease ≥3.0 mL/min/1.73 m2 in the preceding year, were randomized to allopurinol or placebo. The primary outcome was change in eGFR up to 104 weeks using the CKD-EPI creatinine equation. This post hoc subgroup analysis describes outcomes in 352 participants according to baseline serum urate level (normouricemic and hyperuricemic [serum urate >6 mg/dL in women and >7 mg/dL in men], and tertiles of baseline serum urate level). Results: At baseline, 65 (18.5%) and 287 (81.5%) participants had normouricemia and hyperuricemia, respectively. The mean serum urate level in the normouricemic group was 5.9 mg/dL (4.8 mg/dL for women, 6.1 mg/dL for men), and mean serum urate in the hyperuricaemic group was 8.7 mg/dL (8.3 mg/dL for women and 8.9 mg/dL for men). There were no significant differences in change in eGFR between allopurinol and placebo in normouricemic (mean difference [MD] 0.35, 95%CI -2.72 to 3.42 mL/min/1.73 m2/year) and hyperuricemic (MD -0.06, 95%CI -1.20 to 1.08 mL/min/1.73 m2/year) participants (interaction P value = 0.84). The mean serum urate levels in the lowest, middle and highest tertiles were 6.3 mg/dL, 8.0 mg/dL and 10.0 mg/dL, respectively. The result for the primary outcome was consistent across all tertiles of baseline serum urate level (interaction P value for subgroup analysis = 0.49). Conclusions: In CKD patients at risk of progression, the effect of allopurinol on eGFR decline was not modified by baseline serum urate. Funding: Government Support - Non-U.S.

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