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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
The evidence of BK virus infection will be measured by viruria \>500 copies.
Time frame: From baseline to 30 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia \>500 copies.
Time frame: From baseline to 30 days
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).
Time frame: From baseline to 30 days
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
The evidence of BK virus infection will be measured by viruria \>500 copies.
Time frame: From baseline to 120 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia \>500 copies.
Time frame: From baseline to 120 days
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).
Time frame: From baseline to 120 days
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
The evidence of BK virus infection will be measured by viruria \>500 copies.
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Time frame: From baseline to 210 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia \>500 copies.
Time frame: From baseline to 210 days
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).
Time frame: From baseline to 210 days
Number of Participants With Viruria >500 Copies
Participants will experience less BK infection episodes based on viruria reported with \>500 copies.
Time frame: at 300 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia \>500 copies.
Time frame: at 300 days
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).
Time frame: at 300 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Time frame: From baseline to 30 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Time frame: From baseline to 120 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Time frame: From baseline to 210 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Time frame: at 300 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria
Time frame: From baseline to 30 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
Time frame: From baseline to 120 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
Time frame: From baseline to 210 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
Time frame: at 300 days