Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- speed of the graft warming
研究概览
简要总结
Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.
详细描述
Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.
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
- None
入排标准
- 年龄范围
- 12 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weight - >6 kg
- •male or female
- •recipient of first kidney graft either from standard criteria deceased or live donor
- •end stage renal disease or congenital nephrotic syndrome -
排除标准
- •Blood group (ABO) incompatible transplantation
- •presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
- •multiorgan transplantation
- •previous transplant
- •patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
- •patients with haemolytic-uraemic syndrome (HUS) -
研究组 & 干预措施
eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
干预措施: eculizumab (Drug)
结局指标
主要结局
speed of the graft warming
时间窗: at the time of engraftment
The speed of the graft surface warming in the range 15-20°C is accessed on the the infrared video record, taken during graft reperfusion by Nec Thermo Tracer.
次要结局
- graft morphology changes(one year after transplantation)
- One-year graft and patient survival, as well as rejection and infection rates will be calculated(one year after Tx)
- primary graft function(first week after Tx)
研究者
Michael Kaabak
professor
Russian Academy of Medical Sciences