Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial - Full Text View

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. )

First Received on February 16, 2007. Last Updated on May 19, 2009 History of Changes

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

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 II

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:

MedlinePlus related topics: High Blood Pressure Liver Diseases Liver Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus Immunoglobulins Globulin, Immune

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:

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):

Benítez CE, Puig-Pey I, López M, Martínez-Llordella M, Lozano JJ, Bohne F, Londoño MC, García-Valdecasas JC, Bruguera M, Navasa M, Rimola A, Sánchez-Fueyo A. ATG-Fresenius treatment and low-dose tacrolimus: results of a randomized controlled trial in liver transplantation. Am J Transplant. 2010 Oct;10(10):2296-304.

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 February 12, 2012