Study Stopped
Experimental arm (induction + low dose tacrolimus) not effective.
Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial
ATEGE-LIVER
Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning.
1 other identifier
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedMay 20, 2009
May 1, 2009
3.1 years
February 16, 2007
May 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (5)
Graft survival
1 year
Patient survival
1 year
Incidence of opportunistic infections
1 year
Incidence of acute/chronic rejection
1 year
Incidence of hypertension, renal failure, diabetes, hyperlipidemia
1 year
Interventions
ATG-Fresenius 9 mg/kg at induction
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Recipient of a primary liver graft
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Fresenius AGcollaborator
- Astellas Pharma Inccollaborator
Study Sites (1)
Hospital Clinic Barcelona, University of Barcelona
Barcelona, 08036, Spain
Related Publications (1)
Benitez CE, Puig-Pey I, Lopez M, Martinez-Llordella M, Lozano JJ, Bohne F, Londono MC, Garcia-Valdecasas JC, Bruguera M, Navasa M, Rimola A, Sanchez-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. doi: 10.1111/j.1600-6143.2010.03164.x.
PMID: 20883560DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Sanchez-Fueyo
Hospital Clinic Barcelona, Barcelona, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
June 1, 2006
Primary Completion
July 1, 2009
Last Updated
May 20, 2009
Record last verified: 2009-05