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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Standard (tacrolimus based standard therapy without induction) |
|
| 2 Standard of Care | Active Comparator | Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Biological | Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from biopsy-proven acute rejection (including humoral rejection) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the impact of Thymoglobulin on kidney function after transplant | 6 months | |
| Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| USC University Hospital |
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| Label | URL |
|---|---|
| US FDA Approved Full Prescribing Information for Thymoglobulin® | View source |
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| Corticosteroid | Drug | For a minimum of 3 months |
|
| Tacrolimus | Drug | Between Day 3 the last dose of Thymoglobulin |
|
| Mycophenolate Mofetil | Drug | for at least 1 month posttransplant |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, San Fransisco Hospital | San Francisco | California | 94143 | United States |
| University of Colorado Hospital and Health Sciences Center | Denver | Colorado | 80262 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Fairview University Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| University of Texas Health Science Center at San Antonio, University Hospital | San Antonio | Texas | 78229 | United States |
| VCU Medical Center | Richmond | Virginia | 23298 | United States |
| Toronto University Hospital - UHN | Toronto | Ontario | M5G 2N2 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D012059 | Rejection, Psychology |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| D000305 | Adrenal Cortex Hormones |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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