NCT00189826已完成3 期
A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver 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
- 475
- 主要终点
- Incidence of and time to biopsy-proven acute rejections
研究概览
简要总结
To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
详细描述
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.
排除标准
- •Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).
- •Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
- •Patients with serum creatinine > 200 µmol/l..
研究组 & 干预措施
1
Active Comparator
干预措施: tacrolimus (Drug)
2
Experimental
干预措施: tacrolimus (Drug)
结局指标
主要结局
Incidence of and time to biopsy-proven acute rejections
时间窗: 12 months
次要结局
- Incidence of acute rejections(12 months)
研究者
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