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ACTIVE NOT RECRUITING
NCT03266393
PHASE4

Envarsus XR® in Adolescent Renal Transplant Recipients

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

DRUG

Envarsus XR

Once daily sustained-release tacrolimus

DRUG

Tacrolimus

Twice daily immediate-release tacrolimus

Locations (1)

UCLA Transplantation Services

Los Angeles, California, United States