Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
This study has been completed.
Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00117689
First received: June 30, 2005
Last updated: March 17, 2015
Last verified: March 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Dysfunction Rejection, Transplant Transplantation, Liver |
Biological: Thymoglobulin Drug: Corticosteroid Drug: Tacrolimus Drug: Mycophenolate Mofetil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Freedom from biopsy-proven acute rejection (including humoral rejection) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Explore the impact of Thymoglobulin on kidney function after transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 75 |
| Study Start Date: | April 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Standard (tacrolimus based standard therapy without induction)
|
Biological: Thymoglobulin
Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
Other Name: [Anti-thymocyte Globulin (rabbit)]
Drug: Tacrolimus
Between Day 3 the last dose of Thymoglobulin
Drug: Mycophenolate Mofetil
for at least 1 month posttransplant
|
|
Active Comparator: 2 Standard of Care
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
|
Drug: Corticosteroid
For a minimum of 3 months
Drug: Tacrolimus
Between Day 3 the last dose of Thymoglobulin
Drug: Mycophenolate Mofetil
for at least 1 month posttransplant
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117689
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117689
Locations
| United States, Alabama | |
| University of Alabama, Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| USC University Hospital | |
| Los Angeles, California, United States, 90033 | |
| University of California, San Fransisco Hospital | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| University of Colorado Hospital and Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Minnesota | |
| Fairview University Medical Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Washington University Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| University of Texas Health Science Center at San Antonio, University Hospital | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| VCU Medical Center | |
| Richmond, Virginia, United States, 23298 | |
| Canada, Ontario | |
| Toronto University Hospital - UHN | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Canada, Quebec | |
| Royal Victoria Hospital | |
| Montreal, Quebec, Canada, H3A 1A1 | |
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
More Information
Additional Information:
| Responsible Party: | Genzyme, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00117689 History of Changes |
| Other Study ID Numbers: | Thymo102700103 |
| Study First Received: | June 30, 2005 |
| Last Updated: | March 17, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
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 |
Additional relevant MeSH terms:
|
Liver Diseases Digestive System Diseases Mycophenolate mofetil Mycophenolic Acid Tacrolimus Antilymphocyte Serum Calcineurin Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 26, 2016