Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation

"Group 1 Donor Specific Regulation (DSR) +, MPA monotherapy~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."

"Group 2 : Donor specific regulation (DSR) + standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"

"Group 3 : Donor specific regulation (DSR) - standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."