NCT00150020已完成4 期
Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients With GI Intolerance
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
- 728
- 试验地点
- 1
- 主要终点
- Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance
研究概览
简要总结
The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Males and females aged 18-75 years.
- •Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
- •Recipients who are at least 4 weeks post renal transplantation.
- •Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
- •Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.
排除标准
- •Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
- •Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
- •Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance
时间窗: within 3 months
次要结局
- Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events(within 3 months)
- Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS)(within 1 month)
- Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection(within 3 months)
- Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups(after 3 months)
研究者
研究点 (1)
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