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ATG-Fresenius Treatment and Low-Dose Tacrolimus: Results of a Randomized Controlled Trial in Liver Transplantation.

Author(s): 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

Affiliation(s): Liver Unit, Hospital Clinic Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain Bioinformatic Platform, CIBEREHD, Barcelona, Spain Liver Transplant Unit, Surgical Department, Hospital Clinic Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain.

Publication date & source: 2010-10, Am J Transplant., 10(10):2296-304.

We report the results of a prospective randomized controlled trial in liver transplantation assessing the efficacy and safety of antithymocyte globulin (ATG-Fresenius) plus tacrolimus monotherapy at gradually decreasing doses. Patients were randomized to either: (a) standard-dose tacrolimus plus steroids;or (b) peritransplant ATG-Fresenius plus reduced-dose tacrolimus monotherapy followed by weaning of tacrolimus starting 3 months after transplantation. The primary end-point was the achievement of very low-dose tacrolimus (every-other-day or once daily dose with <5 ng/mL trough levels) at 12 months after transplantation. Acute rejection occurring during the first 3 months after transplantation was more frequent in the ATG group (52.4% vs. 25%). Moreover, late acute rejection episodes occurred in all recipients in whom weaning was attempted and no recipients reached the primary end-point. This motivated the premature termination of the trial. Tacrolimus trough levels were lower in the ATG-Fresenius group but no benefits in terms of improved renal function, lower metabolic complications or increased prevalence of tolerance-related biomarkers were observed. In conclusion, the use of ATG-Fresenius and tacrolimus at gradually decreasing doses was associated with a high rate of rejection, did not allow for the administration of very low doses of tacrolimus and failed to provide detectable clinical benefits. ClinicalTrials.gov identifier:NCT00436722. (c)2010 The Authors Journal compilation(c)2010 The American Society of Transplantation and the American Society of Transplant Surgeons.

Page last updated: 2010-10-05

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