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NCT04773392 · ClinicalTrials.gov registry record · Phase 4
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
A Phase 4 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT04773392 is a Phase 4 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 20 participants.
The verdict
NCT04773392, a Phase 4 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.
Interventions
- DRUG Twice-daily Tacrolimus
- DRUG Once-daily envarsus XR
- DRUG Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)
- DRUG Methylprednisolone, prednisone
- DRUG Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2024-02-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04773392
The ClinicalTrials.gov registry entry for NCT04773392 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Twice-daily Tacrolimus is the first listed.
NCT04773392 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04773392 about?
NCT04773392 is a clinical study titled "Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR". The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacr...
What is the current status of trial NCT04773392?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2021-11-23. Estimated completion is 2024-02-23.
What interventions are being tested in trial NCT04773392?
The interventions under investigation include: Twice-daily Tacrolimus (DRUG), Once-daily envarsus XR (DRUG), Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) (DRUG), Methylprednisolone, prednisone (DRUG), Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA) (DRUG).
Who is sponsoring clinical trial NCT04773392?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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