Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection
Condition: Renal Transplant Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Study Group; Control Group
Intervention description: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.; Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Envarsus

Summary:

      The purpose of this study is to assess if the use of Envarsus in place of
      Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce
      incidence of BK infection. Efficacy evaluations will include measurement of urine and serum
      BK values at specified time points and review of any biopsy for BK virus nephropathy.
      Incidence of rejection, graft failure, and graft dysfunction will also be measured at
      specified time points.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years of age at the time of study entry

          -  Recipient of a deceased or living donor kidney transplantation

          -  Maintenance immunosuppression consisting of tacrolimus/ mycophenolate mofetil
             (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day)

          -  Patient is less than or at 8 weeks post transplant with a negative serum BK Virus
             screen at 3-4 weeks post transplant

          -  Patient has a tacrolimus drug dose/concentration of > 1 with therapeutic tacrolimus
             levels.

          -  Women of childbearing potential defined as all women physiologically capable of
             becoming pregnant, must have reviewed Mycophenolate Risk Evaluation and Mitigation
             Strategy (REMS) and have a negative pregnancy test upon study entry.

          -  Female (and male) subjects with reproductive potential must agree to use a highly
             effective method of birth control for the duration of the study. Please note that
             according to the US product information for MMF/MPA, two reliable forms of
             contraception must be used simultaneously unless female sterilization, male
             sterilization, post-menopausal status or total abstinence is the chosen method.

        Exclusion Criteria:

          -  Inability or unwillingness of a patient to give written informed consent or comply
             with study protocol

          -  History of graft loss from acute rejection within 1 year after any previous kidney
             transplant

          -  History of previous liver, heart, pancreas, or lung transplant

          -  History of cellular rejection of current allograft prior to enrollment.

          -  Serum BK virus ≥500 copies/ml by polymerase chain reaction (PCR) at the time of study
             entry

          -  Female subjects who are pregnant or breast feeding

          -  Participation in any other studies with investigational drugs or regimens in the
             preceding year from the time of study entry

          -  Any condition or prior treatment which, in the opinion of the investigator, precludes
             study participation

          -  Patients requiring the use of azathioprine or a class of drugs that inhibit the
             mammalian target of rapamycin (mTOR inhibitors)

          -  Patients with active peptic ulcer disease