Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.

Astellas Pharma Inc627 enrolled

Overview

To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There is evidence that reduced steroid usage could further decrease the onset of diabetes mellitus, hypertension and viral infections combined with high efficacy for patients and graft survival. Since the use of MMF in liver transplantation is becoming an alternative in the rescue setting this could contribute to a steroid-free immunosuppressive approach.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

627

Conditions

Liver Transplantation

Interventions

tacrolimusDRUG

Immunosuppression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included. Exclusion Criteria: * Recipient of an auxiliary graft * Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s). * Patient is requiring ongoing dosing with corticosteroids. * Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease * Patient or donor is known to be HIV positive. * Patient is allergic or intolerant to study medication

Locations (41)

Unnamed facility

Ghent, Belgium

Outcomes

Primary Outcomes

Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation

Time frame: 3 months

Secondary Outcomes

Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection.

Time frame: 3 months

Data from ClinicalTrials.gov

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