NCT00367146已完成不适用
MMF After Pediatric Liver Transplantation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
研究概览
简要总结
The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term.
The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients after pediatric liver transplantation
- •no acute rejections for the last half year
排除标准
- •concomitant malign disease (e.g. ptld)
- •neutropenia (granulocytes <1000/µl)
- •systemic infection
- •thrombopenia (<80/nl)
结局指标
主要结局
safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections
时间窗: 1, 3, 6, 9, 12, 24 month
次要结局
- incidence of infections(1, 3, 6, 9, 12, 24 month)
- incidence of chronic kidney disease(12, 24 month)
- incidence of ptld (post transplant lymphoproliferative disease)(1, 3, 6, 9, 12, 24 month)
研究者
研究点 (2)
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