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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:
Collaborators:
Fresenius AG
Astellas Pharma Inc
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00436722
First received: February 16, 2007
Last updated: May 19, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Patient survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of opportunistic infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of acute/chronic rejection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of hypertension, renal failure, diabetes, hyperlipidemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital Clinic of Barcelona

Additional 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
Study First Received: February 16, 2007
Last Updated: May 19, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Antilymphocyte Serum
Tacrolimus
Immunoglobulins
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013