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NCT04278729 · ClinicalTrials.gov registry record · Phase 1
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT04278729 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 22 participants.
The verdict
NCT04278729, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy control subjects. Comparing differences in steady-state apixaban PK/PD parameters between subjects with NS and healthy volunteers will be essential to identifying a safe and effective apixaban dose and dose administration schedule for future randomized controlled trials (RCTs).
Interventions
- DRUG Apixaban 5 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2023-09-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04278729
The ClinicalTrials.gov registry entry for NCT04278729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Apixaban 5 MG is the first listed.
NCT04278729 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04278729 about?
NCT04278729 is a clinical study titled "A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome". This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy control subjects. Co...
What is the current status of trial NCT04278729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-04-14. Estimated completion is 2023-09-22.
What interventions are being tested in trial NCT04278729?
The interventions under investigation include: Apixaban 5 MG (DRUG).
Who is sponsoring clinical trial NCT04278729?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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