NCT00238966已完成4 期
A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)
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
- 187
- 主要终点
- Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.
研究概览
简要总结
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.
次要结局
- Safety based on renal function within 6 months after medication switch.
- Pharmacokinetics (PK) in a randomized subpopulation.
- Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
- Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
- Graft survival and patient survival 6 months post medication switch.
研究者
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