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Abstract：
BACKGROUND: We investigate whether Intensive uric acid (UA)-lowering therapy (ULT) provides increased renal protection compared with standard therapy in chronic kidney disease (CKD) patients.
METHODS: This was a multicenter randomized controlled trial. Only CKD patients with hyperuricemia were included in this study. The participants were randomly assigned to either the Intensive therapy group (target serum UA level ≥ 4.0 mg/dL and < 5.0 mg/dL) or the standard therapy group (serum UA level ≥ 6.0 mg/dL and < 7.0 mg/dL). ULT was performed using topiroxostat, a non-purine-type selective xanthine oxidase inhibitor. The primary endpoint was change in the logarithmic value of urine albumin to the creatinine ratio (ACR) between baseline and week 52 of the treatment.
RESULTS: Three hundred fifty-two patients were included in the full analysis set. In the Standard therapy group, mean serum UA was 8.23 mg/dL at baseline and 6.13 mg/dL at 52 weeks. In the Intensive therapy group, mean serum UA was 8.15 mg/dL at baseline and 5.25 mg/dL at 52 weeks. There was no significant difference in changes in log ACR at 52 weeks between the Intensive therapy and the Standard therapy groups.
CONCLUSIONS: This study did not reveal the benefit of Intensive ULT to improve albuminuria levels. (UMIN000026741 and jRCTs051180146).
METHODS: This was a multicenter randomized controlled trial. Only CKD patients with hyperuricemia were included in this study. The participants were randomly assigned to either the Intensive therapy group (target serum UA level ≥ 4.0 mg/dL and < 5.0 mg/dL) or the standard therapy group (serum UA level ≥ 6.0 mg/dL and < 7.0 mg/dL). ULT was performed using topiroxostat, a non-purine-type selective xanthine oxidase inhibitor. The primary endpoint was change in the logarithmic value of urine albumin to the creatinine ratio (ACR) between baseline and week 52 of the treatment.
RESULTS: Three hundred fifty-two patients were included in the full analysis set. In the Standard therapy group, mean serum UA was 8.23 mg/dL at baseline and 6.13 mg/dL at 52 weeks. In the Intensive therapy group, mean serum UA was 8.15 mg/dL at baseline and 5.25 mg/dL at 52 weeks. There was no significant difference in changes in log ACR at 52 weeks between the Intensive therapy and the Standard therapy groups.
CONCLUSIONS: This study did not reveal the benefit of Intensive ULT to improve albuminuria levels. (UMIN000026741 and jRCTs051180146).
摘要：
背景：我们研究了在慢性肾脏病（CKD）患者中，与标准治疗相比，强化尿酸（UA）治疗（ULT）是否能提高肾脏保护作用。
方法：这是一项多中心随机对照试验。本研究仅包括高尿酸血症的CKD患者。参与者被随机分配到强化治疗组（目标血清UA水平≥4.0mg/dL和<5.0mg/dL）或标准治疗组（血清UA水平≥6.0mg/dL和<7.0mg/dL）。ULT使用托比罗司他进行，一种非嘌呤型选择性黄嘌呤氧化酶抑制剂。主要终点是基线和治疗第52周之间尿白蛋白与肌酐比率（ACR）的对数值的变化。
结果：三百五十二例患者被纳入完整的分析集。在标准治疗组中，基线时平均血清UA为8.23mg/dL,52周时平均UA为6.13mg/dL.在强化治疗组中，基线时平均血清UA为8.15mg/dL,52周时平均UA为5.25mg/dL.强化治疗组和标准治疗组之间在52周时logACR的变化没有显著差异。
结论：本研究未揭示强化ULT对改善白蛋白尿水平的益处。（UMIN000026741和jRCTs051180146）。
方法：这是一项多中心随机对照试验。本研究仅包括高尿酸血症的CKD患者。参与者被随机分配到强化治疗组（目标血清UA水平≥4.0mg/dL和<5.0mg/dL）或标准治疗组（血清UA水平≥6.0mg/dL和<7.0mg/dL）。ULT使用托比罗司他进行，一种非嘌呤型选择性黄嘌呤氧化酶抑制剂。主要终点是基线和治疗第52周之间尿白蛋白与肌酐比率（ACR）的对数值的变化。
结果：三百五十二例患者被纳入完整的分析集。在标准治疗组中，基线时平均血清UA为8.23mg/dL,52周时平均UA为6.13mg/dL.在强化治疗组中，基线时平均血清UA为8.15mg/dL,52周时平均UA为5.25mg/dL.强化治疗组和标准治疗组之间在52周时logACR的变化没有显著差异。
结论：本研究未揭示强化ULT对改善白蛋白尿水平的益处。（UMIN000026741和jRCTs051180146）。
