A Prospective, Randomized, Open, Multicenter Study to Evaluate the Efficacy and Tolerability of Induction Therapy With a Single High-Dose Anti-T-Lymphocyte Globulin (ATG) in Renal Transplant Patients With a Kidney From a Non-Heart-Beating Donor and Tacrolimus, Mycophenolate Mofetil, and Steroids as Basic Immunosuppression.
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of initial delayed graft function (defined as need for dialysis)
研究概览
简要总结
One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. The increased ischemia-reperfusion injury results in an increased immune activation, which can lead to more injury of the kidney and additional acute rejections. The hypothesis of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have additional favourable effects. To investigate this half of the patients is treated with additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not diminished during the first days after transplantation to investigate whether ATG has special effects on ischemia-reperfusion injury.
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
- •Non-heart-beating-donors (Maastricht III/IV)
- •Female patients of childbearing age agree to maintain effective birth control practice during the study.
排除标准
- •Pregnant or lactating women at the time of randomization.
- •Patients and donors are ABO incompatible.
- •Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
- •Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
- •Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
- •Patients, who are HIV positive.
- •Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP).
- •Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
- •Patients with pulmonary oedema or with other signs of overhydration.
研究组 & 干预措施
ATG
One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone)
干预措施: ATG Fresenius (Drug)
结局指标
主要结局
Incidence of initial delayed graft function (defined as need for dialysis)
时间窗: Within three months after transplantation
次要结局
- Patient and graft survival(At 3 months after transplantation)
- Duration of initial delayed graft failure(Within 3 months after transplantation)
- Incidence of primary never-functioning grafts(Within 3 months after transplantation)
- Incidence of acute rejections (biopsy proven)(Within 3 months after transplantation)
- Renal function as determined by MDRD(At 1, 2, 3 months after transplantation)
- Proteinuria(At 1, 2, 3 months after transplantation)
- Percentage of patients with arterial hypertension(At 3 months after transplantation)
- Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs)(At 3 months after transplantation)
- Percentage of hyperlipidemic patients(At 3 months after transplantation)
- Percentage of post transplant diabetes mellitus(During 3 months after transplantation)
- Incidence of cytomegalovirus infection(During 3 months after transplantation)
- Incidence of tumours/PTLD(At 3 months after transplantation)
- Incidence of other infections(During 3 months after transplantation)
- Microalbuminuria(At 1, 2, 3 months after transplantation)