Induction Therapy of Thymoglobulin Versus Basiliximab in the Prevention of Acute Rejection After Pediatric Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 958
- 试验地点
- 5
- 主要终点
- Acute rejection (AR)
研究概览
简要总结
The goal of this observational study is to compare the efficacy of two most commonly used induction therapy for the prevention of acute rejection (AR) after renal transplantation in children. The main question it aims to answer is:
Is basiliximab (anti-CD25 monoclonal antibody) induction therapy effective and safe in preventing AR after kidney transplantation in children compared with anti-thymoglobulin polyclonal antibodies induction therapy?
The transplant and follow-up data of participants will be retrospectively collected.
Researchers will compare the rate of AR to see if basiliximab (anti-CD25 monoclonal antibody) induction therapy is a better option for certain pediatric kidney transplant recipients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving the kidney graft from a deceased donor
- •Basiliximab or rATG induction therapy was used in perioperative period
排除标准
- •Recipients with pre-transplant calculated panel reactive antibodies (cPRA) >10%
- •Recipients of combined liver, pancreas or heart transplantation
- •No induction or other induction therapy was used in perioperative period
- •Recieving the kidney graft from a living donor
研究组 & 干预措施
Basilliximab induction group
Basiliximab was administered intravenously 4 hours before kidney graft reperfusion and at day 4 after kidney transplantation. For pediatric patients weighing > 30kg, the dose of Basiliximab was 20mg, otherwise was 10mg.
干预措施: Basiliximab Injection (Drug)
rATG induction group
Rabbit antithymoglobulin (rATG) was administered intravenously during kidney transplantation (pre-reperfusion) and 1-2 days after transplantation. The dose was about 0.5-1 mg/kg per day.
干预措施: rabbit ATG (Drug)
结局指标
主要结局
Acute rejection (AR)
时间窗: From baseline, kidney transplantation to data collection completion (June 30, 2023)
The clinical diagnosis of AR is based on a significant increase in serum creatinine and the exclusion of other causes. The diagnosis of biopsy-confirmed AR is based on relevant histological changes.
次要结局
- Renal graft survival(From baseline, kidney transplantation to data collection completion (June 30, 2023))
- Cytomegalovirus (CMV) viremia(From baseline, kidney transplantation to data collection completion (June 30, 2023))
- Pneumonia(From baseline, kidney transplantation to data collection completion (June 30, 2023))
研究者
Gang Chen
Professor
Tongji Hospital