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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The purpose of this study is to compare kidney function, long term patient and graft survival, and incidence of acute rejection in liver transplant recipients between one group receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of liver transplant recipients having immediate administration of tacrolimus without any induction immunosuppression.
Renal insufficiency following liver transplantation in adult recipients is a major cause of morbidity and a major contributor to mortality. One of the key factors contributing to this renal dysfunction is the use of calcineurin inhibitors. There is some evidence to suggest that the first 7-10 days following liver transplantation are crucial in terms of renal function and the ability to avoid the use of nephrotoxic agents such as calcineurin inhibitors may have a significant impact on long-term outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus |
|
| 2 | Active Comparator | patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin (rabbit) | Drug | 1.5mg/kg per dose with the first dose initiated in the operating room prior to reperfusion of the transplanted liver. It will then be administered again on post operative day #1, 3 and 5 for a total cumulative dose of 6mg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters | Post operative day #1, month 6 and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| patient and graft survival, incidence of acute rejection, incidence of active CMV disease, incidence of other infections, any adverse events or serious adverse events associated with the use of thymo induction therapy | post op days 1-6, months 3,6, 9, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Grant, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Fisher NC, Nightingale PG, Gunson BK, Lipkin GW, JM. N. Chronic renal failure following liver transplantation: a retrospective analysis Transplantation 1998; 66 (1): 59. 2. Gonwa TA, Mai ML, Melton LB, et al. End-stage renal disease (ESRD) after orthotopic lvier transplantation (OLTX) using calcineurin-based immunotherapy. Transplantation 2001; 72: 1934. 3. Moreno JM, Cuervas-Mons V, Rubio E, et al. Chronic renal dysfunction after liver transplantation in adult patients: prevelance, risk factors, and impact on mortality. Transplant Proc 2003; 35 (5): 1907. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2018 | |
| Reset | Mar 9, 2018 | |
| Release | Nov 26, 2023 | |
| Reset | Dec 15, 2023 | |
| Release | Dec 20, 2023 | |
| Reset | Jan 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2018 | Mar 9, 2018 | |||
| Nov 26, 2023 |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| tacrolimus | Drug | Tacrolimus will be administered orally on post op day #1 as per standard of care. |
|
|
| Dec 15, 2023 |
| Dec 20, 2023 | Jan 16, 2024 |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |