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Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection

Primary Purpose

Renal Transplant Infection

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Study Group

Control Group

About this trial

This is an interventional treatment trial for Renal Transplant Infection focused on measuring Envarsus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Participants Will Experience Less BK Infection Episodes Based on Viruria Results.

The evidence of BK virus infection will be measured by viruria >500 copies.

Participants Will Experience Less BK Infection Episodes Based on Viremia Results.

The evidence of BK virus infection will be measured by viremia >500 copies.

Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.

The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).