NCT00397358撤回4 期
Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Change from baseline in fasting triglyceride levels.
研究概览
简要总结
This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
详细描述
This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 informed consent
- •CAPD/APD on dialysis for at least 3 months
- •Elevated fasting triglyceride levels
排除标准
- •enrolled in another study requiring IRB approval
- •allergy to starch-based polymers
- •glycogen storage disease
- •maltose or isomaltose intolerance
- •active alcohol/substance abuse
- •Pregnant or nursing
- •received an investigational drug within 30 days of screening
结局指标
主要结局
Change from baseline in fasting triglyceride levels.
次要结局
未报告次要终点
研究者
研究点 (6)
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