A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 16
- 主要终点
- Freedom from biopsy-proven acute rejection (including humoral rejection)
研究概览
简要总结
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation
- •Serum creatinine > 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation
- •Ages greater than or equal to 18 years
- •If female, must not be lactating; must have a negative serum beta-human chorionic gonadotropin (HCG) test within 7 days prior to Study Day 0 (Day of Transplant); and must agree to practice an acceptable and reliable form of contraception during the study
- •Signed informed consent
排除标准
- •Living donor or multiple organ transplants
- •Prior solid organ or bone marrow transplant recipient
- •Fulminant hepatic failure
- •Status 1 transplants
- •ABO incompatible transplants
- •Transplants utilizing livers from non heart-beating donors
- •Liver transplant candidates with > 6 weeks of analysis
- •Donor with positive serology for hepatitis B surface antigen (HBsAg)
- •Evidence of human immunodeficiency virus (HIV)
- •Autoimmune hepatitis
- •History of chronic steroid or immunosuppressant use in the 90 days prior to transplant, except for inhaled corticosteroids to treat asthma
- •Recipient of investigational therapy within 90 days prior to transplant procedure
- •Known contraindication to administration of rabbit anti-thymocyte globulin
- •Acute viral illness
- •History of malignancy within 5 years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence, and/or hepatocellular carcinoma
- •Illness other than primary liver disease (e.g. severe ischemic heart disease, left ventricular dysfunction, or pulmonary disease), which, in the opinion of the investigator, may significantly increase the risk of the transplantation procedure
- •Current drug and alcohol abuse that, in the opinion of the investigator, puts subjects at risk for poor compliance (no drug test required)
研究组 & 干预措施
1
Standard (tacrolimus based standard therapy without induction)
干预措施: Thymoglobulin (Biological)
1
Standard (tacrolimus based standard therapy without induction)
干预措施: Tacrolimus (Drug)
1
Standard (tacrolimus based standard therapy without induction)
干预措施: Mycophenolate Mofetil (Drug)
2 Standard of Care
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
干预措施: Corticosteroid (Drug)
2 Standard of Care
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
干预措施: Tacrolimus (Drug)
2 Standard of Care
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Freedom from biopsy-proven acute rejection (including humoral rejection)
时间窗: 6 months
次要结局
- Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.(12 months)
- Explore the impact of Thymoglobulin on kidney function after transplant(6 months)