The Effects of Allopurinol on the Progression of CKD According to Baseline Kidney Function: Prespecified Analyses of the CKD-FIX Trial

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Background: The CKD-FIX trial showed that allopurinol did not slow the decline of estimated glomerular filtration rate (eGFR) over 104 weeks in patients with chronic kidney disease (CKD) and risk of progression. In this study, we assessed the effect of allopurinol on change in eGFR according to CKD stage at baseline. Methods: Three hundred and sixty nine adults with CKD stage 3 or 4, no history of gout, and who were at risk of progression (identified by either urinary albumin-tocreatinine ratio ≥265 mg/g or eGFR decrease ≥3.0 mL/min/1.73 m2 in the preceding year) were randomized to receive allopurinol or placebo. Primary outcome was rate of change in eGFR up to 104 weeks using the CKD-EPI creatinine equation. This pre-specified subgroup analysis describes outcomes in patients with CKD stage 3 and stage 4. Results: At baseline, 178 (49%) patients had CKD stage 3 (mean eGFR 41 mL/min/1.73 m2, mean serum urate 7.9 mg/dL) and 185 (51%) patients had CKD stage 4 (mean eGFR 23.1 mL/min/1.73 m2, mean serum urate 8.4 mg/dL). In patients with CKD stage 3, change in eGFR did not differ between the allopurinol (-3.67 mL/min/1.73 m2/year, 95% CI -4.97 to -2.38) and placebo (-3.34 mL/min/1.73 m2/year, 95% CI -4.59 to -2.09) groups (mean difference [MD], -0.33 mL/min/1.73 m2/year, 95% CI -2.13 to 1.47). In patients with CKD stage 4, there was no difference in change in eGFR between the allopurinol (-2.89 mL/min/1.73 m2/year, 95% CI -3.74 to -2.03) and placebo (-2.89 mL/min/1.73 m2/year, 95% CI -3.73 to -2.04) groups (MD, 0.00 mL/min/1.73 m2/year, 95% CI -1.18 to 1.17). The interaction P value for subgroup analysis was 0.87. Conclusions: In CKD patients at risk of progression, the effect of allopurinol on eGFR decline was not modified by baseline kidney function. Funding: Government Support - Non-U.S.

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