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

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:

ATG-Fresenius 9 mg/kg at induction

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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

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