Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection

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). Patient
will be managed using standard of care for the investigator's center (thymoglobulin
induction, tacrolimus/mycophenolate/prednisone). Target tacrolimus level is 8-12 for the
first 6 months and 6-9 thereafter. BK urine/serum is monitored at 1, 3, 6, 9, 12 months. A
population of 100 patients is calculated to show significant difference for p value < .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 month 1, whom have a concentration/dose of < 1 and a steady state therapeutic
level will be eligible. Patients will be converted to envarsus at 20% reduction in 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 month 1 and
concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.

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)

- Pt 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 wither 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 participant 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