Status:
COMPLETED
Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Renal Transplant Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03762473
Start Date
May 9 2019
End Date
March 16 2022
Last Update
July 27 2023
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294