Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
NCT ID: NCT00117689
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2005-04-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Standard (tacrolimus based standard therapy without induction)
Thymoglobulin
Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
Tacrolimus
Between Day 3 the last dose of Thymoglobulin
Mycophenolate Mofetil
for at least 1 month posttransplant
2 Standard of Care
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
Corticosteroid
For a minimum of 3 months
Tacrolimus
Between Day 3 the last dose of Thymoglobulin
Mycophenolate Mofetil
for at least 1 month posttransplant
Interventions
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Thymoglobulin
Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
Corticosteroid
For a minimum of 3 months
Tacrolimus
Between Day 3 the last dose of Thymoglobulin
Mycophenolate Mofetil
for at least 1 month posttransplant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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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
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio, University Hospital
San Antonio, Texas, United States
VCU Medical Center
Richmond, Virginia, United States
Toronto University Hospital - UHN
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Countries
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Related Links
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US FDA Approved Full Prescribing Information for Thymoglobulin®
Other Identifiers
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Thymo102700103
Identifier Type: -
Identifier Source: org_study_id
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