Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
- Conditions
- Rejection, TransplantTransplantation, LiverLiver Dysfunction
- Interventions
- Registration Number
- NCT00117689
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Standard of Care Corticosteroid Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy 1 Thymoglobulin Standard (tacrolimus based standard therapy without induction) 2 Standard of Care Mycophenolate Mofetil Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy 1 Tacrolimus Standard (tacrolimus based standard therapy without induction) 1 Mycophenolate Mofetil Standard (tacrolimus based standard therapy without induction) 2 Standard of Care Tacrolimus Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
- Primary Outcome Measures
Name Time Method Freedom from biopsy-proven acute rejection (including humoral rejection) 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
University of California, San Fransisco Hospital
🇺🇸San Francisco, California, United States
University of Colorado Hospital and Health Sciences Center
🇺🇸Denver, Colorado, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Fairview University Medical Center
🇺🇸Minneapolis, Minnesota, United States
Washington University Medical Center
🇺🇸St. Louis, Missouri, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Scroll for more (6 remaining)University of Alabama, Birmingham🇺🇸Birmingham, Alabama, United States