Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection
Condition: Renal Transplant Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This will be a single center prospective case control study. The investigators expect 40% of
      patients will develop BK viruria, 20% BK viremia, 5% BK viral nephropathy (BKVN). Patients
      will be managed using standard of care for the investigator's center (thymoglobulin
      induction, tacrolimus/mycophenolate/prednisone). Target tacrolimus level is 8-12 ng/mL for
      the first 6 months post transplant and 6-9 ng/mL thereafter. BK urine/serum is monitored at
      1, 3, 6, 9, 2 months post transplant. A population of 100 patients is calculated to show
      significant difference for p value < 0.05.

      Population:

      Study Group: Post transplant patients (kidney transplant alone) with standard of care
      immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK
      screening at post-transplant month 1, who have a tacrolimus concentration/dose of < 1 and a
      steady state therapeutic level will be eligible. Patients who consent will be converted to
      Envarsus at 20% reduction in tacrolimus dose.

      Control Group: 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 post-transplant month 1 and
      tacrolimus concentration/dose of < 1 at post-transplant month 1, and BK data available for
      months 2, 3, 6, 9,12 post transplant.
    

Intervention name(s): Study Group; Control Group
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): tacrolimus extended-release tablets; Tacrolimus
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Envarsus