NCT00852969已完成4 期
Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
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
- 30
- 试验地点
- 1
- 主要终点
- Change in the Flow Mediated Dilation From Baseline
研究概览
简要总结
The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)
- •HDL-cholesterol <50 for men and <55 for women
- •If taking a statin, stable dose for past one month
- •Glucose <200 mg/dL and HbA1c <9%
- •Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry
排除标准
- •Hospitalization within prior 3 months
- •Any of the following conditions:
- •uncontrolled peptic ulcer disease
- •active liver disease OR abnormal SGOT/SGPT
- •history of adverse reaction to niacin
- •contra-indication to aspirin
- •concurrent fibrate therapy
- •history of gout
- •serum phosphorus levels below 2.7mg/dl
- •Pregnancy
研究组 & 干预措施
Niacin
Active Comparator
干预措施: Niacin (Drug)
Placebo
Placebo Comparator
干预措施: Active Placebo (Drug)
结局指标
主要结局
Change in the Flow Mediated Dilation From Baseline
时间窗: 14 weeks since baseline
Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks
次要结局
- Change in HDL-C From Baseline to 14 Weeks(14 weeks since baseline)
研究者
研究点 (1)
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