Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Incidence of biopsy-proven acute allograft rejection during the first post-transplant year
研究概览
简要总结
To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.
详细描述
The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year.
Eligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Third or fourth renal graft or
- •Current anti-HLA antibodies above or equal to 30% at the last evaluation or
- •Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
- •A second graft if the first was lost within 2 years because of rejection.
- •Patients who gave their informed consent and are able to understand the scope of the study
排除标准
- •Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
- •Transplantation from a non-heart beating donor
- •Transplantation of two kidneys from the same donor
- •Patients with generalized infection at the time of transplantation
- •Women in child-bearing age who do not plan to use efficient contraception
研究组 & 干预措施
1, ATG
Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids
干预措施: Thymoglobulin (ATG) (Drug)
2, Daclizumab
Dacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids
干预措施: Daclizumab (Drug)
结局指标
主要结局
Incidence of biopsy-proven acute allograft rejection during the first post-transplant year
时间窗: acute rejection proved by graft biopsy
次要结局
- Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.(graft dysfunction)
- Proportion of patients who experienced more than one episode of acute allograft rejection(graft dysfunction, biopsies)
- Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)(number of anti-lymphocyte treatment required for acute rejection episodes)
- Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm(graft dysfunction and biopsies)
- Banff grade of the first rejection episode(graft biopsy)
- Incidence of adverse events in the two treatment arms at 1 year(number of adverse events reported by the investigators)
- Incidence of delayed graft function(number of patient who required hemodialysis during the first week post transplantation)
- Graft function at 1 year(serum creatinine and estimated glomerular filtration rate)
- Graft and patient survival at 1 year(number of graft failures and/or deaths)