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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: Clinical Trial Phase 4 study, sponsored by University of Southern California.
NCT04773392 is a Phase 4 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.
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 |
Why NCT04773392 stopped before completion
NCT04773392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Twice-daily Tacrolimus is the first listed.
NCT04773392 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04773392's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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