NCT00420472终止4 期
An Open-Label Study to Evaluate the Effect on Quality of Life of Switching Kidney Transplant Patients From Reduced Dose EC-MPS to a Higher Than the Equimolar Dose of CellCept
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 试验地点
- 7
- 主要终点
- Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
研究概览
简要总结
This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •first or second kidney transplant;
- •EC-MPS therapy for >=6 months, with a stable dose for >=2 months;
- •lower than recommended dose of EC-MPS (<1440g/day) due to gastrointestinal complaints.
排除标准
- •patients who have participated in this study before;
- •patients currently participating in another clinical trial, or who participated in one during the last 30 days.
结局指标
主要结局
Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
次要结局
- Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.
研究者
研究点 (7)
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