Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy ; a Pilot Phase II Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- serious infectious complication
研究概览
简要总结
Graft nephrectomy is associated with massive allo-sensitization following this event. The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Investigators propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy. The primary endpoint evaluated here is the occurrence of serious infectious complications following graft nephrectomy, with a treatment by Tocilizumab. Secondary endpoints evaluated here are - to evaluate all complications after graft nephrectomy, - and the Tocilizumab effectiveness to reduce anti-HLA antibodies at one year post nephrectomy.
详细描述
Background: graft nephrectomy is associated with massive allo-sensitization following this event The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Moreover, a systemic inflammatory response syndrome can occur which could lead to serious patient's complications, in case of early graft thrombosis. To date, no treatment or strategy is available to reduce these risks, after graft nephrectomy. IL-6 is a key cytokine in inflammation, but also in the development of T and B cells activation. This treatment previously demonstrated a major role in the occurrence of allo-antibodies. Tocilizumab is a monoclonal antibody blocking IL6 receptor, previously used with success in kidney transplantation to reduce anti-HLA antibodies mediated rejection.
Objectives: Investigators hypothesize that Tocilizumab is useful to prevent allo-sensitization post graft nephrectomy. They propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult recipients,
- •affiliated to the social security
- •requiring a graft nephrectomy, with a project to retransplantation
排除标准
- •combined transplantations, PRA >20%.
- •Patient under protective measures,
- •Rituximab used for immunosuppression induction
- •Previous transplants not removed,
- •Active infectious complications at graft nephrectomy, need for immunosuppressive treatments after graft nephrectomy,
- •Participation to another interventional studies using Rituximab, polyclonal antibodies, Eculizumab, or Tocilizumab.
- •adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision,
- •pregnancy or breastfeeding.
研究组 & 干预措施
Tocilizumab
Evaluation of the use of Tocilizumab after allograft nephrectomy.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
serious infectious complication
时间窗: 1 year post graft nephrectomy
serious infectious complication rate at 1 year post graft nephrectomy
次要结局
- The effectiveness of the treatment(1 year post graft nephrectomy)
- Complications after treatment(1 year post graft nephrectomy)