NCT00154206已完成4 期
A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
研究概览
简要总结
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
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
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of a primary renal transplantation
- •Recipients of a renal transplantation only
排除标准
- •Recipients of a multi-organ transplantation
- •Unable to take an oral medication
- •Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).
- •Other protocol-defined inclusion / exclusion criteria may apply
结局指标
主要结局
Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
次要结局
- Within the 6 and 12 months post transplantation
- Incidence of acute rejection resistant to steroids
- Incidence of graft loss and death
- Renal function by creatinine and creatinine clearance (Schwartz formula)
- Incidence of premature study drug discontinuation due to safety reason
- Pharmacokinetic profile of Myfortic.
- Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.
研究者
研究点 (1)
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