AN OPEN, MULTICENTRE, RANDOMISED PARALLEL GROUP CLINICAL STUDY TO COMPARE SAFETY AND EFFICACY OF TACROLIMUS (FK506) WITH MONOCLONAL ANTI-IL2R ANTIBODIES (DACLIZUMAB) VS TACROLIMUS (FK506) WITH STEROIDS AND EVALUATE PHARMACOKINETICS IN LIVER ALLOGRAFT RECIPIENTS RECEIVING SUBOPTIMAL LIVERS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Incidence of and time to first biopsy-proven and treatment requiring acute rejection
研究概览
简要总结
The purpose of the study is to compare the safety and efficacy of two different tacrolimus based immunosuppressive regimens, one in combination with daclizumab, the other in combination with steroids, in recipients of suboptimal livers.
Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of patients.
详细描述
Open, multicentre, 1:1 randomised, parallel group phase III study to compare safety and efficacy of tacrolimus (FK506) with monoclonal anti-IL2R antibodies (daclizumab) vs tacrolimus (FK506) with steroids and evaluate pharmacokinetics in liver allograft recipients receiving suboptimal livers.
Patients receiving primary suboptimal liver allograft transplantation (from donors > 65 years and/or liver macrosteatosis >15%) will be randomised to one of the following treatment arms:
Group I: steroid bolus (intraoperative) monoclonal anti-IL2R antibodies (daclizumab) induction tacrolimus Group II: steroid bolus (intraoperative) tacrolimus steroids
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Adult patients scheduled to receive a liver transplant
- •Donors older than 65 and/or has liver macrosteatosis >15%
- •Female patients of childbearing potential agree to maintain effective birth control during the study and must have negative pregnancy test at baseline
排除标准
- •Patient has previously received or is receiving an organ transplant other than liver, or a liver re-transplantation.
- •Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer
- •Patient is receiving an auxiliary graft or a bio-artificial liver has been used.
- •Any pathology or medical condition that can interfere with this protocol study proposal
- •Other exclusion applies
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 and treatment requiring acute rejection
时间窗: 3 months
次要结局
- Incidence of acute rejection(3 months)