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NCT03864926 · ClinicalTrials.gov registry record · Phase 4
Envarsus in Delayed Graft Function (E-DGF)
A Phase 4 study of Delayed Graft Function, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03864926: Completed Phase 4 study of Delayed Graft Function, sponsored by University of Wisconsin, Madison.
NCT03864926 is a Phase 4 study of Delayed Graft Function that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 100 participants, below the 358-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03864926, a Phase 4 study of Delayed Graft Function, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.
Primary Outcome
The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Envarsus XR
Study Locations (1)
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-03-18 |
| Est. Completion | 2022-07-22 |
| Phase | Phase 4 |
What the finished NCT03864926 record still lists
NCT03864926 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 358-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Delayed Graft Function appearing as the primary indexed condition, and to 2 interventions - of which Tacrolimus is the first listed.
NCT03864926 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03864926 about?
NCT03864926 is a clinical study titled "Envarsus in Delayed Graft Function (E-DGF)". Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimu...
What is the current status of trial NCT03864926?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2019-03-18. Estimated completion is 2022-07-22.
What conditions does trial NCT03864926 study?
This clinical trial studies the following conditions: Delayed Graft Function.
What interventions are being tested in trial NCT03864926?
The interventions under investigation include: Tacrolimus (DRUG), Envarsus XR (DRUG).
Who is sponsoring clinical trial NCT03864926?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03864926 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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