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NCT03266393 · ClinicalTrials.gov registry record · Phase 4
Envarsus XR® in Adolescent Renal Transplant Recipients
A Phase 4 study of Kidney Transplantation and Renal Transplantation, sponsored by University of California, Los Angeles.
- Active
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT03266393: Active Phase 4 study of Kidney Transplantation and Renal Transplantation, sponsored by University of California, Los Angeles.
NCT03266393 is a Phase 4 study of Kidney Transplantation and Renal Transplantation that is active but no longer recruiting, run by University of California, Los Angeles. The registered enrollment target is 28 participants, below the 267-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03266393, a Phase 4 study of Kidney Transplantation and Renal Transplantation, is active but no longer recruiting, sponsored by University of California, Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Appearance of dnDSA will be assessed by Luminex Single Antigen Bead assay. Patients will be monitored for rejection by measuring serum creatinine, a marker of renal function. If the creatinine level suggests allograft dysfunction, a biopsy will be performed and the tissue assessed by the 2013 Banff Criteria to determine presence of absence of rejection. Incidence rates will be compared across 4 month follow-up periods of each for twice-daily tacrolimus and Envarsus XR® descriptively and using Po
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Envarsus XR
Study Locations (1)
California
- UCLA Transplantation Services - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 4 |
What the registry record for NCT03266393 still lists
NCT03266393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 267-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Kidney Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Tacrolimus is the first listed.
NCT03266393 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03266393 about?
NCT03266393 is a clinical study titled "Envarsus XR® in Adolescent Renal Transplant Recipients". 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 a...
What is the current status of trial NCT03266393?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2019-01-15. Estimated completion is 2023-03-31.
What conditions does trial NCT03266393 study?
This clinical trial studies the following conditions: Kidney Transplantation, Renal Transplantation, Grafting, Kidney.
What interventions are being tested in trial NCT03266393?
The interventions under investigation include: Tacrolimus (DRUG), Envarsus XR (DRUG).
Who is sponsoring clinical trial NCT03266393?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03266393 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03266393's enrollment target sits among peer trials
28 29th of 33 higher than 5 of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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