Clinical trial NCT00117689: Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
Official title: A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Dysfunction
Rejection, Transplant
Transplantation, Liver
Keywords: 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
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-07-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Freedom from biopsy-proven acute rejection (including humoral rejection)
timeFrame: 6 months
Secondary outcomes:
measure: Explore the impact of Thymoglobulin on kidney function after transplant
timeFrame: 6 months
measure: Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Fransisco Hospital
state: California
city: Denver
country: United States
facility: University of Colorado Hospital and Health Sciences Center
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Minneapolis
country: United States
facility: Fairview University Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio, University Hospital
state: Texas
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Toronto
country: Canada
facility: Toronto University Hospital - UHN
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: