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Completed

NCT Number: NCT00117689

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

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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Key information

Conditions

Liver Dysfunction Behavior Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Liver Diseases Male Urogenital Diseases Rejection, Psychology Rejection, Transplant Renal Insufficiency Social Behavior Transplantation, Liver Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto University Hospital - UHN, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thymoglobulin

Biological

Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy

Other names: [Anti-thymocyte Globulin (rabbit)]

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

Primary outcomes

  1. Freedom from biopsy-proven acute rejection (including humoral rejection)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 8, 2005
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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