跳至主要内容
临床试验/NCT02477488
NCT02477488已完成4 期

Optimal Administration of Allopurinol in Dialysis Patients : A Chronotherapy Trial

Maisonneuve-Rosemont Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Change in uric acid levels from baseline

研究概览

简要总结

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows that it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication.

详细描述

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. A study has shown an incidence of fifteen percent of gout in the first five years spent in dialysis and it was associated with an increased mortality. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some studies from the early 1960s demonstrated that it is also dialyzable. At the moment, we do not have strong evidence of the optimal dosage of allopurinol with modern techniques of dialysis. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication. Dosage of uric acid will be performed to assess the efficacy of the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects who receive chronic treatments of hemodialysis at Maisonneuve-Rosemont Hospital
  • Subjects who take allopurinol for at least a month

排除标准

  • Subjects who have had an acute gout attack in the past month
  • Subjects with tumor lysis syndrome
  • Sujects who have a history of hypersensitivity reaction to allopurinol
  • Subjects with hepatic insufficiency
  • Women who are pregnant or planning to become pregnant in the next three months

研究组 & 干预措施

Allopurinol HS

Experimental

Allopurinol at bedtime compared to AM administration

干预措施: Allopurinol (Drug)

结局指标

主要结局

Change in uric acid levels from baseline

时间窗: 6 weeks

Compare the efficacy of allopurinol when given before versus after dialysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Vallée

Nephrologist, M.D., Ph.D., FRCP(C)

Maisonneuve-Rosemont Hospital

研究点 (1)

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