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NCT03373227 · ClinicalTrials.gov registry record · Phase 2
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
A Phase 2 study of Heart Transplant Rejection and Graft Failure, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03373227: Completed Phase 2 study of Heart Transplant Rejection and Graft Failure, sponsored by Baylor Research Institute.
NCT03373227 is a Phase 2 study of Heart Transplant Rejection and Graft Failure that has completed, run by Baylor Research Institute. The registered enrollment target is 50 participants, below the 731-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03373227, a Phase 2 study of Heart Transplant Rejection and Graft Failure, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily tacrolimus (Prograf®) dosing regimen post-cardiac transplantation.
Primary Outcome
Evaluate effect on rejection and graft failure by comparing adverse events in standard of care versus experimental groups
Conditions Studied
Interventions
- DRUG Envarsus
Study Locations (1)
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 2 |
What the finished NCT03373227 record still lists
NCT03373227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 731-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Heart Transplant Rejection appearing as the primary indexed condition, and to 1 intervention - of which Envarsus is the first listed.
NCT03373227 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03373227 about?
NCT03373227 is a clinical study titled "Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen". This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily tacrolimus (Prograf®) dosing regimen post-cardiac transplantation.
What is the current status of trial NCT03373227?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-12-04. Estimated completion is 2023-12-30.
What conditions does trial NCT03373227 study?
This clinical trial studies the following conditions: Heart Transplant Rejection, Graft Failure, Compliance, Patient.
What interventions are being tested in trial NCT03373227?
The interventions under investigation include: Envarsus (DRUG).
Who is sponsoring clinical trial NCT03373227?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03373227 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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