NCT00239031已完成3 期
Multicentre, Controlled, Prospective, Randomized, Open-label Clinical Trial to Compare Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced Dose Cyclosporine Microemulsion (CsA-ME) Vs EC-MPS Plus Standard Dose CsA-ME in Elderly de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids
适应症
干预措施
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
- 117
- 主要终点
- The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.
研究概览
简要总结
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
The aim of this study is to compare the renal function, 6 months after transplant, in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 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
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Enteric-Coated Mycophenolate Sodium (Drug)
结局指标
主要结局
The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.
次要结局
- Incidence of treatment failure (biopsy-proven and/or treated acute rejection, graft loss, death or loss to follow-up at 6 and 12 months;
- Incidence of biopsy proven acute rejection at Month 6 and 12
- Incidence of graft loss at Month 6 and 12
- Rate of delayed graft function (DGF) and the time to adequate renal function (serum creatinine < 2,5 mg/dL);
- Pharmacokinetics of MPA and MPAG at Day 15, Month 3 and Month 6
研究者
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