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NCT03979365 · ClinicalTrials.gov registry record · Phase 4
Envarsus XR Compared to Immediate Release Tacrolimus
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 261
- Enrollment target
NCT03979365: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT03979365 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 261 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03979365, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 261 participants
- Enrollment target
Study Summary
The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.
Primary Outcome
The CIRS is a questionnaire that assesses five symptoms (from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events \[PRO-CTCAE\]) that have been shown to be associated with calcineurin inhibitors. These symptoms include trembling hands, muscle cramps, muscle weakness, swollen gums, and increased hair growth. Each symptom is based on symptom severity in the last 7 days scaled from 0 (none) - 4 (very severe). The cumulative score ranges from 0-20, with higher
Interventions
- DRUG Envarsus XR
- DRUG Tacrolimus twice daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2022-03-29 |
| Phase | Phase 4 |
What the finished NCT03979365 record still lists
NCT03979365 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Envarsus XR is the first listed.
NCT03979365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03979365 about?
NCT03979365 is a clinical study titled "Envarsus XR Compared to Immediate Release Tacrolimus". The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of...
What is the current status of trial NCT03979365?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 261 participants. The study started on 2019-07-18. Estimated completion is 2022-03-29.
What interventions are being tested in trial NCT03979365?
The interventions under investigation include: Envarsus XR (DRUG), Tacrolimus twice daily (DRUG).
Who is sponsoring clinical trial NCT03979365?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03979365's enrollment target sits among peer trials
261 326th of 2000 higher than 1,675 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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