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). 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.

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