Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Outcomes after kidney transplantation have been significantly enhanced with the advances made
in immunosuppressive therapies. Tacrolimus is currently marketed as an extended-release
once-daily formulation dosing option for patients, decreasing pill burden and possibly
decreasing adverse effects. Some transplant recipients have been shown to have higher dosage
requirements. According to the literature, this can be linked to genetic disparities in the
metabolism of tacrolimus.. This potential complication, where differences on specific genes
alters metabolism of tacrolimus, can increase difficulty in getting to a therapeutic drug
level for immunosuppresants and is one large factor that contributes to the fact that kidney
transplant survival rates differ between patients. Due to the enhanced bioavailability of
Meltdose formulation once-daily extended-release tacrolimus, its de novo use in recent
research and practice has been shown to expedite achievement of target tacrolimus trough
concentrations. De novo use of once-daily tacrolimus formulations is understudied. Through a
prospective investigational study, we aim to determine the optimal strategy for de novo
dosing of once-daily extended release tacrolimus (MeltDose formulation) for kidney transplant
recipients at Temple University Hospital.