Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- Asymmetric Dimethylarginine physiological marker
研究概览
简要总结
The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.
详细描述
Aim of The Work:
1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of:
- Primary endpoint:
• Reduction in Asymmetrical Dimethylarginine (ADMA) 2. Secondary endpoints:
- Assessing the change in serum High sensitivity C-reactive protein (hsCRP)
- Assessing the change in serum Uric acid - The criteria for inclusion:
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Outpatients on maintenance hemodialysis.
- •Age from 18-70 years old.
- •Serum Uric Acid level 7.0 mg/dL or more.
- •Stable clinical condition (no hospitalization in the previous 3 months)
- •Informed consent in accordance with the Declaration of Helsinki.
排除标准
- •Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
- •History of hypersensitivity to febuxostat.
- •Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
- •Participant in an another clinical trial within the past 4 weeks.
- •Judged to be unsuitable as a subject by the attending physician
研究组 & 干预措施
Group I
This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.
干预措施: Febuxostat (Drug)
Group II
This Group of Patients will receive Placebo along with their standard Treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Asymmetric Dimethylarginine physiological marker
时间窗: 2 months
Asymmetric dimethylarginine (ADMA) physiological marker for assessing endothelial dysfunction will be measured for all the anticipated 50 patients at time zero and by the end of the two months.
次要结局
- Uric Acid , physiological parameter(2 months)
- High sensitivity C-reactive protein physiological marker(2 months)
研究者
Mona AlShahawey AlSayed Ghazy
Administrator at clinical pharmacy department .
Ain Shams University