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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
75
Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
For a minimum of 3 months
Between Day 3 the last dose of Thymoglobulin
for at least 1 month posttransplant
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
...and 6 more locations
Freedom from biopsy-proven acute rejection (including humoral rejection)
Time frame: 6 months
Explore the impact of Thymoglobulin on kidney function after transplant
Time frame: 6 months
Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.
Time frame: 12 months
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