Prospective Multicentric, Randomized, Open-labeled, in Parallel Groups, Study to Assess the Benefit/Risk of an Induction Treatment With Anti-Thymocyte Globulins (ATG) Versus Basiliximab in Kidney Transplant Patients Displaying Low Immunological Risk But High Susceptibility to Delayed Graft Function.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Occurrence of a delayed graft function
研究概览
简要总结
The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First kidney transplantation
- •No anti HLA immunization prior transplantation
- •A risk of DGF higher than 40% calculated by the score DGFS (DGFS >= 0.4)
- •Written informed consent
排除标准
- •Previous or combined other transplantations
- •Non heart beating donors
- •Living donors
- •Pre-emptive transplantation
- •Patients on peritoneal dialysis
- •Leucopenia lower than 3000/mm3
- •Thrombopenia lower than 100 000/mm3
- •Donor EBV positive / recipient EBV Negative
- •Pregnant or lactating women
- •Patients under guardianship
- •Previous and current history of cancer and/or lymphoma
- •Current history of HCV or HBV or HIV infection
研究组 & 干预措施
ATG
The first infusion of Thymoglobuline® begins before the kidney reperfusion. In case of a patient with a functional arteriovenous fistula or a high-flow venous catheter, the infusion of Thymoglobuline® can begin just after the randomization pre operatively. When the patient has no available arteriovenous fistula for the Thymoglobuline® infusion, it is necessary to install a high-flow vein (central vein) by the anesthesiologist, and to begin the perfusion as soon as possible intra-operatively before the reperfusion of the kidney. The dose of Thymoglobuline® per infusion is 1.5mg/kg. The duration of each infusion is between 6 to 24 hours.
The total duration of the Thymoglobuline® administration is 4 days (starting at and including the first day of the surgery).
干预措施: Anti-Thymocyte Globulins treatment (Drug)
Basiliximab
The first infusion of Simulect® begins within the two hours before the surgery. There is no need of central venous catheter or arteriovenous fistula to infuse the Simulect®. The duration of the infusion is 30 minutes. Each dose of Simulect® is 20 mg. The first infusion of Simulect® is displayed on Day 0 (within the two hours before the surgery) and the second infusion 3 days afterward (Day 4).
干预措施: Basiliximab treatment (Drug)
结局指标
主要结局
Occurrence of a delayed graft function
时间窗: 7 days
Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation.
次要结局
- Evolution of estimated glomerular filtration rate (eGFR)(15 days)
- Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).(3 months)
- Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation(3 months)
- Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.(3 months)
- Duration of the delayed graft function(7 days)
- Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR(3 months)
- Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation(3 months)
- Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.(15 days)