Low Dose Thymoglobulin As Induction Agent on Prednisone-Free Regimens of Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Rates of Acute Cellular Rejection Between Study Group
研究概览
简要总结
This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.
详细描述
Detailed Study Design:
This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.
The investigators will obtain the following information at the time of consent:
- Type of renal transplant (living vs cadaveric)
- HLA matching
- CMV status of donor and recipient
- EBV status of donor and recipient
- Creatinine prior to transplantation
- Urinalysis at the time of transplantation
- Primary renal disease
- Weight of the renal transplant
- BMI of the recipient and donor
- Age of the donor and recipient
- Sex of the donor and recipient
- White blood cell count
- Hemoglobin
- Platelets
- History of infections
- History of malignancies
During each of the clinic visits the investigators will obtain the following information:
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential Adult Renal Transplant Patients -
排除标准
- •Sensitized Renal Transplant Patients
研究组 & 干预措施
Thymoglobulin 0.75mg/kg dose
The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.
干预措施: Thymoglobulin 0.75mg/kg dose (Drug)
Thymoglobulin 1.25mg/kg dose
The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
Rates of Acute Cellular Rejection Between Study Group
时间窗: 1 year from date of transplant
Incidence of Biopsy Proven Acute Rejection at 1 year post transplant:
次要结局
- , "Total Number of Adverse Events, Including Any Infections, Leucopenia, and Malignancy"(1 year from date of transplant)
