DSR-guided Tacrolimus Withdrawal to Myfortic Monotherapy in Liver Transplantation
The hypothesis to be tested is that donor-microchimerism in specific cell populations
promotes the development of donor-specific regulation which in turn allows for long-term
maintenance therapy with a single drug (Myfortic) in selected patients leading to superior
long-term outcomes. Subjects will be enrolled post-transplantation and will be liver
transplant recipients who meet the eligibility and exclusion criteria. We will use
post-transplant monitoring for donor-specific immunologic regulation (DSR+/ DSA negative) to
direct the withdrawal of patients to Myfortic monotherapy. Donor microchimerism, DSR, DSA
development will be performed on samples obtained every six months from patients on study.
The ultimate objective of the study is to use immunologic monitoring to develop a rational
approach to achieving individualized immunosuppression for liver transplant patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
MDRD estimation of GFR.
24 months post randomization/enrollment
Will Burlingham, PhD
University of Wisconsin, Madison
United States: Food and Drug Administration
|University of Wisconsin- Madison||Madison, Wisconsin 53792|