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临床试验/NCT01280617
NCT01280617已完成不适用

Low Dose Thymoglobulin As Induction Agent on Prednisone-Free Regimens of Renal Transplant Recipients

Lahey Clinic1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

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:

  1. Type of renal transplant (living vs cadaveric)
  2. HLA matching
  3. CMV status of donor and recipient
  4. EBV status of donor and recipient
  5. Creatinine prior to transplantation
  6. Urinalysis at the time of transplantation
  7. Primary renal disease
  8. Weight of the renal transplant
  9. BMI of the recipient and donor
  10. Age of the donor and recipient
  11. Sex of the donor and recipient
  12. White blood cell count
  13. Hemoglobin
  14. Platelets
  15. History of infections
  16. 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

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

Experimental

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

Experimental

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)

研究者

发起方
Lahey Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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