Trial Outcomes & Findings for Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection (NCT NCT03762473)

NCT ID: NCT03762473

Last Updated: 2023-07-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 89 participants
• Primary outcome timeframe: From baseline to 30 days
• Results posted on: 2023-07-27

Participant Flow

Participant milestones

Measure	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. Study Group: 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.	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. 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.
Overall Study STARTED	44	45
Overall Study COMPLETED	43	45
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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. Study Group: 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.	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. 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.
Overall Study Death	1	0

Baseline Characteristics

the patient who died was not included in the statistics

Baseline characteristics by cohort

Measure	Study Group n=43 Participants 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. Study Group: 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.	Control Group n=45 Participants 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. 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.	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • the patient who died was not included in the statistics	0 Participants n=7 Participants • the patient who died was not included in the statistics	0 Participants n=5 Participants • the patient who died was not included in the statistics
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants • the patient who died was not included in the statistics	45 Participants n=7 Participants • the patient who died was not included in the statistics	85 Participants n=5 Participants • the patient who died was not included in the statistics
Age, Categorical >=65 years	3 Participants n=5 Participants • the patient who died was not included in the statistics	0 Participants n=7 Participants • the patient who died was not included in the statistics	3 Participants n=5 Participants • the patient who died was not included in the statistics
Age, Continuous	50.19 years n=5 Participants	50.19 years n=7 Participants	50.19 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	45 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 30 days

Population: data not gathered for this time period.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 30 days

Population: data not gathered for this time period

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 30 days

Population: data was not gathered at this time period

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 120 days

Population: no data was collected for this time period.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 120 days

Population: data was not collected for this time period.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 120 days

Population: data was not collected for this time period.

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 210 days

Population: data was not collected for this time period.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 210 days

Population: data was not collected for this time period.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 210 days

Population: data was not collected for this time period.

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at 300 days

Participants will experience less BK infection episodes based on viruria reported with >500 copies.

Outcome measures

Measure	Study Group n=43 Participants 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. Study Group: 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.	Control Group n=45 Participants 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. 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.
Number of Participants With Viruria >500 Copies	14 Participants	22 Participants

PRIMARY outcome

Timeframe: at 300 days

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

Outcome measures

Measure	Study Group n=43 Participants 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. Study Group: 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.	Control Group n=45 Participants 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. 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.
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.	8 Participants	15 Participants

PRIMARY outcome

Timeframe: at 300 days

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).

Outcome measures

Measure	Study Group n=43 Participants 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. Study Group: 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.	Control Group n=45 Participants 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. 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.
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From baseline to 30 days

Population: data was not collected for this time period.

Safety will be assessed for all Grade 3 or higher infection

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 120 days

Population: data was not collected for this time period.

Safety will be assessed for all Grade 3 or higher infection

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 210 days

Population: data was not collected for this time period.

Safety will be assessed for all Grade 3 or higher infection

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at 300 days

Safety will be assessed for all Grade 3 or higher infection

Outcome measures

Measure	Study Group n=43 Participants 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. Study Group: 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.	Control Group n=45 Participants 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. 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.
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to 30 days

Population: data was not collected for this time period.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 120 days

Population: data was not collected for this time period.

This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 210 days

Population: data was not collected for this time period.

This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 300 days

This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria

Outcome measures

Measure	Study Group n=43 Participants 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. Study Group: 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.	Control Group n=45 Participants 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. 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.
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.	0 Participants	0 Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Graham Towns, MD

University of Alabama at Birmingham

Phone: (205)934-1801

Email: gtowns@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place