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Envarsus XR® in Adolescent Renal Transplant Recipients

Study acronym: EnvarsusXR
StatusActive, Not Recruiting
PhasePhase 4
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Meghan Pearl, MD to University of California, Los Angeles
    • Primary completion date: Jan 15, 2022 to Mar 31, 2023
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study completion date: Jan 15, 2023 to Mar 31, 2023
    v5
  2. Trial status: Not Yet Recruiting to Enrolling by Invitationv4 Show 5 more changesShow less
    • Primary completion date: Jun 1, 2020 to Jan 15, 2022
    • Study completion date: Jun 1, 2020 to Jan 15, 2023
    • Start date changed from estimate of Nov 1, 2018 to Jan 15, 2019
    • Study description revised
    • Eligibility criteria shortened, about 1 word
  3. Primary and study completion dates: Aug 1, 2019 to Jun 1, 2020
    • Start date: Aug 15, 2018 to Nov 1, 2018
    v3
  4. Start date: Nov 1, 2017 to Aug 15, 2018
    • Eligibility criteria shortened, about 37 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03266393
Lead Sponsor University of California, Los Angeles
Collaborators: Veloxis Pharmaceuticals
Conditions
(from sponsor)		 Kidney Transplantation, Renal Transplantation, Grafting, Kidney
Related terms Rejection, Psychology
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov