Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- intima media thickness
研究概览
简要总结
The purpose of this study in patients with stage 4 and 5 chronic kidney disease is to determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness, calcification and pulse wave velocity.
详细描述
This is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. Eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. Following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. Patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. The original medication will be continued. The total follow-up will be 48 weeks.
At the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (CRP, hs CRP, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent
- •Over 18 years of age
- •Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines
排除标准
- •Life span of less than one year
- •Alcohol abuse
- •Transaminases > 2.5 times the upper limit
- •Diabetes mellitus
- •Pregnancy
- •Cardiac disease with marked limitation of functional capacity (NYHA III or IV)
- •Use of immunosuppressant agents
结局指标
主要结局
intima media thickness
时间窗: 48 weeks
次要结局
- carotid artery calcifications(48 weeks)
- inflammation(48 weeks)
- lipid profile(48 weeks)
- metabolic profile(48 weeks)
- pulse wave velocity(48 weeks)
- nutritional status(48 weeks)
- bone density(48 weeks)