Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial (ATEGE-LIVER)
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ClinicalTrials.gov Identifier: NCT00436722
Recruitment Status :
(Experimental arm (induction + low dose tacrolimus) not effective.)
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.
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 ]
Secondary Outcome Measures :
Graft survival [ Time Frame: 1 year ]
Patient survival [ Time Frame: 1 year ]
Incidence of opportunistic infections [ Time Frame: 1 year ]
Incidence of acute/chronic rejection [ Time Frame: 1 year ]
Incidence of hypertension, renal failure, diabetes, hyperlipidemia [ Time Frame: 1 year ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age > 18 years
Recipient of a primary liver graft
Absence of any of our 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