NCT01324934终止3 期
Prospective, Randomized, Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of Immunosuppression Following a Heart-beating Cadaveric Renal Transplantation Based on the Use of Rabbit Anti-T-lymphocyte Serum, Tacrolimus and Mycophenolate, Free of Concomitant Corticosteroids From the Start of Immunosuppression
Neovii Biotech10 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2006年10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
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection
研究概览
简要总结
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Study Group
Active Comparator
immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic
干预措施: ATG-Fresenius S (Drug)
结局指标
主要结局
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection
时间窗: 1 year
次要结局
- Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections(1 year)
- Incidence and duration of initial DGF(1 year)
- Renal function(1 year)
- Patient and Graft survival(1 year)
- Safety endpoints are the incidence of AEs/SAEs and ADRs(1 year)
研究者
研究点 (10)
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