Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients
Condition: Kidney Transplant
Intervention: Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant
Intervention description: Study drug (tacrolimus extended-release) initiated at 0.13/mg/kg/day for all patients
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Adult patient who is 18 years of age or older receiving a kidney transplant at the Temple
        University Hospital's Kidney Transplant Program who are capable of understanding consent
        and volunteer to take part in the study

        Exclusion Criteria:

        Scheduled for multiple organ transplant at enrollment Non-English speaking Pregnant women
        Moderate-severe hepatic impairment (Child Pugh > 10 or bilirubin > 2) Existing
        contraindications to tacrolimus-based products including known hypersensitivity to
        tacrolimus or any other component of the formulation Receiving concomitant medications
        known to have strong drug-drug interaction potential with tacrolimus including fluconazole,
        voriconazole, posaconazole, isavuconazole, itraconazole, ketoconazole, diltiazem,
        verapamil, metronidazole, erythromycin, clarithromycin, rifampin, rifabutin, rifapentine,
        phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, St. John's Wort,
        efavirenz, neivrapine, etravirine, atazanavir, darunavir, fosamprenavir, indinavir,
        lopinavir, ritonavir, nelfinavir, saquinavir, tipranavir, cobicistat