NCT04983160已完成2 期
Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial. Modulation of Cellular Mediators and Repair Endothelial Damage in Patients With Chronic Renal Disease Through Inhibition of Xanthine Oxidase
Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年2月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells
研究概览
简要总结
The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms.
详细描述
The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms, evaluating the plasma concentration of angiogenic factors, microparticles of endothelial cells and the cell number circulating endothelial progenitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Patients willing and able to give informed consent for participation in the study
- •Ability to understand study procedures and to comply with it for the duration of the study.
- •Subjects of both sexes, the age range between 18 and 70 years old.
- •Serum uric acid above 7 mg / dl.
- •Estimated glomerular filtration rate by MDRD abbreviated formula less than 60 ml / min / 1.73 m2 and above 15 ml / min / 1.73 m
- •Stability of renal function (serum creatinine increase without exceeding 50% in the three months before the start of the study).
- •Clinically stable in terms of no hospitalizations of cardiovascular events in the 3 months before the study began.
排除标准
- •Drop active in the 60 days prior to study initiation.
- •Use of allopurinol within 60 days preceding baseline
- •Active infections within 30 days prior to baseline.
- •Patients with systemic inflammatory disease
- •Infection with HIV, Hepatitis C and Hepatitis B.
- •History of cancer within 5 years prior to the first dose of study medication
- •Chronic liver disease.
- •Immunosuppressive therapy.
- •Pregnant women, breastfeeding or planning to become pregnant.
- •Allergy or sensitive to allopurinol.
- •Addiction to drugs or alcohol, in the opinion of the investigator, may interfere with compliance with study requirements.
- •Inability or unwillingness of the individual or legal guardian or representative to give written informed consent.
研究组 & 干预措施
Allopurinol
Active Comparator
干预措施: Allopurinol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells
时间窗: Data collected after 4 weeks, 8 weeks and 12 weeks.
Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD
次要结局
- Level of micro inflammation(After patient visit (0 weeks, 4, 8 and 12 weeks))
- Level of oxidative stress(After patient visit (0 weeks, 4, 8 and 12 weeks))
- Level of endothelial dysfunction(After patient visit (0 weeks, 4, 8 and 12 weeks))
- Blood pressure(Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours)
- Glomerular filtration ratio(After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks))
- Microalbuminuria / Proteinuria(Daily, using first urine of the day as a sample.)
研究者
研究点 (1)
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