NCT00238940已完成3 期
A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 55
- 主要终点
- Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
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
- •- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
次要结局
- Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
- Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
- Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
- Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
- Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.
研究者
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