Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The rationale for this study is to determine if Campath-1H can be used in liver transplant
recipients to induce a state of immunological unresponsiveness that would not only eliminate
the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids
utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the
severity of histologic recurrence of certain autoimmune diseases responsible for causing
liver failure. The investigator propose a randomized prospective open label trial in 50 liver
transplant recipients who will received a calcineurin inhibitors free immunosuppressive
protocol that consist of a single dose of Campath-1H as an induction therapy in association
with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group
will receive a standard immunosuppressive regimen, which consists of IV steroid induction
therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no
induction antibody therapy.