NCT00149942已完成4 期
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Gastro-intestinal adverse events before switch versus 3 months after switch
研究概览
简要总结
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.
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
- •Kidney or liver transplanted patients
- •Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events
排除标准
- •Recent graft rejection before the study
- •Other pre-existing conditions that may cause gastro-intestinal complaints
- •Use of other drugs known to cause gastro-intestinal complaints
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Gastro-intestinal adverse events before switch versus 3 months after switch
次要结局
- Frequency of adverse events
- Frequency of infections
- Time to the first biopsy-proven rejection after conversion.
- Severity of biopsy-proven rejections after conversion.
- Proportion of patients who had graft loss after conversion.
研究者
研究点 (1)
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