drugset / Trial / NCT03762473

Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection

NCT03762473 ↗

Phase 2 Completed 89 enrolled University of Alabama at Birmingham
Non-randomizedParallel-groupOpen-labelTreatment

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 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.

Timeline

Start
2019-05-09
Primary completion
2022-03-16
Completion
2022-03-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule — —