NCT01028092已完成3 期
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 18
- 主要终点
- calculated renal function with MDRD equation
研究概览
简要总结
This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who has given written informed consent to participate in the study
- •First or second single transplantation of a recipient (male or female) older than 60 years old
- •Donor older than 60 years old
- •PRA < 30%
排除标准
- •Living donor
- •Third transplantation
- •PRA > 30%
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •Recipient of multi-organ transplant
- •Active major infections (HBV, HCV, HIV)
- •Loss of a first graft for immunologic issues
- •Anemia (<9g/l) or leucopenia (<2500/mm3)
研究组 & 干预措施
Control
Active Comparator
anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids
干预措施: Anti R-IL2 + Cyclosporine (Drug)
CNI-free
Experimental
Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids
干预措施: Thymoglobulin + Everolimus (Drug)
Switch
Experimental
anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids
干预措施: Anti R-IL2 + Cyclosporine then Everolimus (Drug)
结局指标
主要结局
calculated renal function with MDRD equation
时间窗: 12 months
次要结局
- Acute rejection rate(12 months)
- GFR calculated with Cockcroft Gault formula(12 months)
- Adverse events(12 months)
- Patient and graft survival rate(12 months)
研究者
研究点 (18)
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