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Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117689
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Liver Dysfunction Rejection, Transplant Transplantation, Liver Biological: Thymoglobulin Drug: Corticosteroid Drug: Tacrolimus Drug: Mycophenolate Mofetil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from biopsy-proven acute rejection (including humoral rejection) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Explore the impact of Thymoglobulin on kidney function after transplant [ Time Frame: 6 months ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117689


Locations
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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
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Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00117689    
Other Study ID Numbers: Thymo102700103
First Posted: July 8, 2005    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
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:
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Liver Diseases
Digestive System Diseases
Mycophenolic Acid
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents