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

This study has been terminated.
(Experimental arm (induction + low dose tacrolimus) not effective.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436722
First Posted: February 19, 2007
Last Update Posted: May 20, 2009
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.
Collaborators:
Fresenius AG
Astellas Pharma Inc
Information provided by:
Hospital Clinic of Barcelona
  Purpose
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 Intervention Phase
Liver Diseases Drug: ATG (Fresenius Biotech) Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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:
  • Graft survival [ Time Frame: 1 year ]
  • Patient survival [ Time Frame: 1 year ]
  • Incidence of opportunistic infections [ Time Frame: 1 year ]
  • Incidence of acute/chronic rejection [ Time Frame: 1 year ]
  • Incidence of hypertension, renal failure, diabetes, hyperlipidemia [ Time Frame: 1 year ]

Estimated Enrollment: 72
Study Start Date: June 2006
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ATG (Fresenius Biotech)
    ATG-Fresenius 9 mg/kg at induction
    Other Names:
    • ATeGe
    • Anti-lymphocyte immunoglobulin
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT00436722


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miguel navasa, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00436722     History of Changes
Other Study ID Numbers: EudraCT 2005-005635-10
First Submitted: February 16, 2007
First Posted: February 19, 2007
Last Update Posted: May 20, 2009
Last Verified: May 2009

Keywords provided by Hospital Clinic of Barcelona:
Liver
Transplantation
Tolerance
Induction
Tacrolimus
Liver transplantation
Adult

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