A Single Center, Open-label, Single-arm Study to Determine the Safety and Efficacy of a Single Dosing Regimen Eculizumab for Prevention of Antibody-Mediated Rejection (AMR) in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi-LDKTx)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The incidence of AMR within 6 months after transplantation
研究概览
简要总结
The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors
详细描述
Kidney transplantation is considered the best therapy for patients with end-stage renal disease. ABO-incompatible living donor kidney transplantation (ABOi-LDKTx) is one of the strategies to expand the pool of donors. However, the blood group antibodies in recipients can lead to acute rejection, resulting in transplant failure. Before transplantation, the use of rituximab (RTX) to remove B cells; plasmapheresis to eliminate blood group antibodies can mitigate the occurrence of acute rejection and enhance the success rate of transplantation.
The complement system plays a vital role in antibody-mediated rejection (AMR). Eculizumab can target the C5 protein of the complement system and then block the activation. Therefore, we hypothesize that the pretransplant use of eculizumab may prevent the AMR in ABOi-LDKTx.
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
- •aged ≥ 18 years, male or female
- •Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation
- •Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab
- •Be able to understand the informed consent form and willing to comply with the protocol
排除标准
- •Previous splenectomy
- •Any active bacterial or other infection
- •Known or suspected hereditary complement deficiency
- •Known hypersensitivity to the treatment drug or any of its excipients
- •History of Neisseria meningitidis
- •Any health condition that the investigator believes may interfere with the patient's participation, pose additional risks to the patient, or confound with the patient's assessment (e.g. severe cardiovascular or pulmonary disease)
研究组 & 干预措施
Eculizumab
A single dose of eculizumab was given on the Day 0 before the transplant surgery.
干预措施: Eculizumab (Drug)
结局指标
主要结局
The incidence of AMR within 6 months after transplantation
时间窗: 6 months after kidney transplant surgery
次要结局
未报告次要终点
研究者
Tao Lin
Principal Investigator (PI)
West China Hospital