NCT00149929已完成3 期
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients
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
- 246
- 主要终点
- Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
研究概览
简要总结
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301
排除标准
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
次要结局
- Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
- Efficacy of enteric-coated mycophenolate sodium
- Safety of enteric-coated mycophenolate sodium based on AE reporting.
- Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).
研究者
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