Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Endothelial Dependent Dilation From Baseline to Week 12
研究概览
简要总结
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
详细描述
The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:
- Allopurinol therapy and 2) Placebo.
Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2
- •Elevated uric acid levels
- •Age range: more than 18 years old
- •Ability to give informed consent
- •Albumin > 3.0 g/dL
- •BMI < 40 kg/m2
排除标准
- •Life expectancy < 1.0 years
- •Expected to undergo living related kidney transplant in 6 months
- •Pregnant, breast feeding, or unwilling to use adequate birth control
- •History of severe liver disease
- •History of severe congestive heart failure
- •History of hospitalizations within 3 months
- •Active infection, on antibiotics
- •History of Warfarin Use or other medications that are contraindicated with allopurinol
- •Uncontrolled hypertension
- •History of acute gout on Allopurinol
- •History of adverse reaction to Allopurinol
- •Immunosuppressive therapy within the last 1 yr
研究组 & 干预措施
Control
Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.
干预措施: Placebo (Other)
Allopurinol
Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Change in Endothelial Dependent Dilation From Baseline to Week 12
时间窗: Baseline and 12 weeks
Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12
次要结局
- Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12(Baseline and 12 weeks)
- Change in C-reactive Protein From Baseline to Week 12(Baseline and 12 weeks)
- Change in Oxidized Low Density Lipoprotein From Baseline to Week 12(Baseline and 12 weeks)
- Change in Serum Interleukin-6 From Baseline to Week 12(Baseline and 12 weeks)