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Envarsus XR® in Adolescent Renal Transplant Recipients
Sponsor: University of California, Los Angeles
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.
Official title: A Prospective, Randomized, Single-center, Pilot Study of Envarsus XR® to Examine Safety, Medication Adherence, and Patient Reported Outcomes in Adolescent Renal Transplant Recipients
Key Details
Gender
All
Age Range
13 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2019-01-15
Completion Date
2023-03-31
Last Updated
2023-02-09
Healthy Volunteers
No
Interventions
Envarsus XR
Once daily sustained-release tacrolimus
Tacrolimus
Twice daily immediate-release tacrolimus
Locations (1)
UCLA Transplantation Services
Los Angeles, California, United States