Trials / Completed
CompletedNCT04278729
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apixaban 5 MG | 1 - 5 mg tablet taken orally twice a day |
Timeline
- Start date
- 2021-04-14
- Primary completion
- 2023-09-22
- Completion
- 2023-09-22
- First posted
- 2020-02-20
- Last updated
- 2023-09-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04278729. Inclusion in this directory is not an endorsement.