Back to resultsEvaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
About this trial
This is an interventional prevention trial for Liver Dysfunction focused on measuring Anti-T cell antibodies, Primary Liver Transplantation and Renal Dysfunction, Liver Transplant Rejection, Induction Therapy with reduction of Calcineurin inhibitors, Primary Liver Transplantation, Primary Transplant Rejection, Transplantation, Liver, Rejection, Transplant
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Sites / Locations
- University of Alabama, Birmingham
- USC University Hospital
- University of California, San Fransisco Hospital
- University of Colorado Hospital and Health Sciences Center
- Mayo Clinic Jacksonville
- University of Miami
- Fairview University Medical Center
- Washington University Medical Center
- University of Nebraska
- Mount Sinai Medical Center
- University of Cincinnati Medical Center
- Baylor University Medical Center
- University of Texas Health Science Center at San Antonio, University Hospital
- VCU Medical Center
- Toronto University Hospital - UHN
- Royal Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2 Standard of Care
Standard (tacrolimus based standard therapy without induction)
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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