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NCT04521569 · ClinicalTrials.gov registry record · Early Phase 1
Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System
A Early Phase 1 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 47
- Enrollment target
NCT04521569: Completed Early Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT04521569 is a Early Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 47 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04521569, a Early Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to see if adding a drug called Regadenoson to the EVLP circulation reservoir during perfusion of marginal donor lungs will help increase the likelihood that the donor lungs will become usable for transplantation.
Primary Outcome
The primary endpoint is rehabilitation (yes, no) for marginal donor lungs that undergo ex-vivo perfusion using a "lung box" as assessed by the transplant surgeon and utilizing the "Toronto Method" clinical protocol. Rate of rehabilitation is defined as the proportion of sets of lungs that underwent EVLP with/without Regadenoson treatment and are determined to be eligible for implant.
Interventions
- DRUG Placebo
- DRUG Regadenoson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2024-07-31 |
| Phase | Early Phase 1 |
What the finished NCT04521569 record still lists
NCT04521569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04521569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04521569 about?
NCT04521569 is a clinical study titled "Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System". The purpose of this study is to see if adding a drug called Regadenoson to the EVLP circulation reservoir during perfusion of marginal donor lungs will help increase the likelihood that the donor lungs will become usable for transplantation.
What is the current status of trial NCT04521569?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 47 participants. The study started on 2020-06-22. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT04521569?
The interventions under investigation include: Placebo (DRUG), Regadenoson (DRUG).
Who is sponsoring clinical trial NCT04521569?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04521569's enrollment target sits among peer trials
47 563rd of 2000 higher than 1,436 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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