NCT01244659撤回3 期
An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients
EMS1 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.
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
- •Age > 18 year old
- •Patient is receiving kidney from live or death donor
- •Kidney donor younger than 65 years old
- •PRA ≤ 30%
- •Negative pregnancy test for women
- •Patient agreement to practice birth control
- •Patient has been fully informed and has given written informed consent
排除标准
- •HLA identical
- •Patient multi-organ transplant recipient
- •Any pathology or past medical condition that can interfere with this protocol
- •Allergy or intolerance of any study medication
研究组 & 干预措施
Tacrolimus from EMS
Experimental
Group 1: Tacrolimus from EMS + Myfortic® + Steroids
干预措施: Tacrolimus from EMS (Drug)
Prograf
Active Comparator
Group 2: Prograf® + Myfortic® + Steroids
干预措施: Prograf (Drug)
结局指标
主要结局
Efficacy
时间窗: day 1 to day 180
Incidence of biopsy confirmed acute rejection
次要结局
- Safety(day 1 to day 180)
研究者
研究点 (1)
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