Clinical Trial

Envarsus XR® in Adolescent Renal Transplant Recipients

Study acronym: EnvarsusXR
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated February 9, 2023 (before its estimated March 31, 2023 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2017-08-25; most recent amendment 2024-03-28.
Status change: Active, Not Recruiting → Terminated 2024-03-28
Status change: Enrolling by Invitation → Active, Not Recruiting 2023-02-07
Status change: Not Yet Recruiting → Enrolling by Invitation 2019-04-15
Trial Details
NCT Number NCT03266393
Lead Sponsor University of California, Los Angeles
Collaborators: Veloxis Pharmaceuticals
Conditions Kidney Transplantation, Renal Transplantation, Grafting, Kidney
Enrollment 28 participants
Start Date 2019-01-15
Primary Completion 2023-03-31 (estimated)
Study Completion 2023-03-31 (estimated)
Updated on ClinicalTrials.gov 2023-02-09