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NCT04420195 · ClinicalTrials.gov registry record · Phase 2
Envarsus XR in Lung Transplant
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT04420195: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT04420195 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04420195, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's standard of care.
Primary Outcome
The primary endpoint is the percentage of patients remaining on Envarsus XR at the 1-year follow-up visit.
Interventions
- DRUG Extended-Release Tacrolimus
- DRUG Immediate-Release Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 2 |
What the finished NCT04420195 record still lists
NCT04420195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Extended-Release Tacrolimus is the first listed.
NCT04420195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04420195 about?
NCT04420195 is a clinical study titled "Envarsus XR in Lung Transplant". Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacr...
What is the current status of trial NCT04420195?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2020-10-23. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT04420195?
The interventions under investigation include: Extended-Release Tacrolimus (DRUG), Immediate-Release Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT04420195?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04420195's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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