An Open, Randomised, Multicenter, Clinical Study to Compare the Safety and Efficacy of Tacrolimus and Minimal Steroids in Combination With Either a Monoclonal Anti-IL2R Antibody (Daclizumab) or Mycophenolate Mofetil in Liver Allograft Transplantation.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 627
- 主要终点
- Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation
研究概览
简要总结
To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
详细描述
This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There is evidence that reduced steroid usage could further decrease the onset of diabetes mellitus, hypertension and viral infections combined with high efficacy for patients and graft survival. Since the use of MMF in liver transplantation is becoming an alternative in the rescue setting this could contribute to a steroid-free immunosuppressive approach.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.
排除标准
- •Recipient of an auxiliary graft
- •Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).
- •Patient is requiring ongoing dosing with corticosteroids.
- •Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease
- •Patient or donor is known to be HIV positive.
- •Patient is allergic or intolerant to study medication
研究组 & 干预措施
1
干预措施: tacrolimus (Drug)
2
干预措施: tacrolimus (Drug)
结局指标
主要结局
Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation
时间窗: 3 months
次要结局
- Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection.(3 months)