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

This study is currently recruiting participants.
Verified by Hospital Clinic of Barcelona, March 2008

Sponsors and Collaborators: Hospital Clinic of Barcelona
Fresenius AG
Astellas Pharma Inc
Information provided by: Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00436722
  Purpose

This is a randomised controlled trail 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 minimisation may promote development of tolerogenic mechanisms allowing the eventual withdrawal of all immunosuppressive therapy.


Condition Intervention Phase
Liver Diseases
Drug: ATG (Fresenius Biotech)
Phase II

MedlinePlus related topics:   Liver Diseases    Liver Transplantation   

ChemIDplus related topics:   Tacrolimus    Globulin, Immune    Immunoglobulins    Tacrolimus anhydrous   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning.

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
Show detailed description  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

Contacts
Contact: Alberto Sanchez-Fueyo, MD     34-93-2274399     afueyo@clinic.ub.es    
Contact: Miguel Navasa, MD     34-93-2274399     mnavasa@clinic.ub.es    

Locations
Spain
Hospital Clinic Barcelona, University of Barcelona     Recruiting
      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

Study ID Numbers:   EudraCT 2005-005635-10
First Received:   February 16, 2007
Last Updated:   March 26, 2008
ClinicalTrials.gov Identifier:   NCT00436722
Health Authority:   Spain: Spanish Agency of Medicines

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

Study placed in the following topic categories:
Antilymphocyte Serum
Liver Diseases
Digestive System Diseases
Tacrolimus
Immunoglobulins

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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