Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Conduct a retrospective study to evaluate the impact of generic conversion in adult
transplant recipients on post transplant outcomes one year prior to conversion to one year
post conversion. Variables for analysis will include but not limited to incidence of
rejection, hospital admission, changes in renal function, changes in transplanted organ
function. All tacrolimus levels and dose changes during this period will be collected and
compared. Additional pharmacokinetic modeling of this data will be performed for comparison.
The prospective study will compare othe relative bioavailability and steady-state
pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study
including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
Phase:
Phase 4
Details
Lead Sponsor:
University of Cincinnati
Collaborators:
Children's Hospital Medical Center, Cincinnati University of Colorado, Denver