Envarsus XR® in Adolescent Renal Transplant Recipients
Status:
Enrolling by invitation
Trial end date:
2023-01-15
Target enrollment:
Participant gender:
Summary
Adolescents commonly experience barriers to adherence that entail forgetfulness, distraction,
poor planning, and scheduling problems. A once daily oral regimen may be superior to the
current regimens that require twice daily dosing. It is currently unclear if Envarsus XR®
would improve outcomes in adolescent organ transplant recipients. Each patient will receive
tacrolimus (twice daily immediate release oral formulation) which they are using as part of
their standard of care immunosuppressive regimen for a portion of the study and Envarsus XR®
(a once daily extended-release oral tacrolimus formulation) for a portion of the study in a
cross-over design. Besides the advantage to adherence behaviors, a sustained-release
tacrolimus preparation may decrease burdensome side effects and increase quality of life.
Following enrollment, each patient will be maintained in the study for 9 months.