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临床试验/NCT03425708
NCT03425708Unknown4 期

Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

The Affiliated Hospital of Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
400
试验地点
1
主要终点
serum uric acid

研究概览

简要总结

To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

详细描述

This study aims to explore the best effective dose and adverse reaction of febuxostat in lowering serum uric acid to low level in patients with Chronic Renal Disease at different stages. To elucidate that low levels of serum uric acid can delay the progression of renal damage. Promote the application of anti uric acid drugs in the treatment of chronic renal failure and delay the progress of CKD in patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-dialysis CKD patients with serum uric acid greater than 7mg/dl.
  • eGFR≥15ml/min/1.73m².
  • Low salt, low protein, low purine diet.

排除标准

  • Take drugs that raise blood uric acid at the same time.
  • Patients with gout attacks.
  • Patients with pregnant, lactating.
  • Autosomal dominant polycystic kidney disease.
  • Patients with poor general condition and multiple organ failure.

研究组 & 干预措施

Treatment group1

Active Comparator

Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.

干预措施: 20mg Febuxostat (Drug)

Treatment group2

Active Comparator

Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.

干预措施: 40mg Febuxostat (Drug)

结局指标

主要结局

serum uric acid

时间窗: up to 6 months

intravenous blood sampling

次要结局

  • serum creatinine(up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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