Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial (ATEGE-LIVER)

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. Identifier: NCT00436722
Recruitment Status : Terminated (Experimental arm (induction + low dose tacrolimus) not effective.)
First Posted : February 19, 2007
Last Update Posted : May 20, 2009
Fresenius AG
Astellas Pharma Inc
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor minimization may promote development of tolerogenic mechanisms allowing the eventual withdrawal of all immunosuppressive therapy.

Condition or disease Intervention/treatment Phase
Liver Diseases Drug: ATG (Fresenius Biotech) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning.
Study Start Date : June 2006
Estimated Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: ATG (Fresenius Biotech)
    ATG-Fresenius 9 mg/kg at induction
    Other Names:
    • ATeGe
    • Anti-lymphocyte immunoglobulin

Primary Outcome Measures :
  1. Proportion of patients who can significantly decrease the doses of tacrolimus 1 year after transplantation (as defined by: tacrolimus administered on alternate days, or daily with trough levels below 5 ng/mL. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Graft survival [ Time Frame: 1 year ]
  2. Patient survival [ Time Frame: 1 year ]
  3. Incidence of opportunistic infections [ Time Frame: 1 year ]
  4. Incidence of acute/chronic rejection [ Time Frame: 1 year ]
  5. Incidence of hypertension, renal failure, diabetes, hyperlipidemia [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Recipient of a primary liver graft
  • Absence of any of our exclusion criteria

Exclusion Criteria:

  • Pretransplant renal failure, defined as serum creatinine > 1.5 mg/dL
  • Severe pretransplant thrombopenia, defined as platelets < 50000/mL
  • Combined liver-kidney transplantation
  • Autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis as causes of liver transplantation
  • Chronic hepatic encephalopathy
  • Living donor liver transplantation
  • Recipient with human immunodeficiency virus infection
  • Severe pretransplant leukopenia, defined as < 1500 leukocytes/mL

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 identifier (NCT number): NCT00436722

Hospital Clinic Barcelona, University of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fresenius AG
Astellas Pharma Inc
Principal Investigator: Alberto Sanchez-Fueyo Hospital Clinic Barcelona, Barcelona, Spain

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Miguel navasa, Hospital Clinic of Barcelona Identifier: NCT00436722     History of Changes
Other Study ID Numbers: EudraCT 2005-005635-10
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: May 20, 2009
Last Verified: May 2009

Keywords provided by Hospital Clinic of Barcelona:
Liver transplantation

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action