drugset / Trial / NCT04278729
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
Phase 1
Completed
22 enrolled
University of North Carolina, Chapel Hill
American College of Clinical Pharmacy · collab
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-04-14
- Primary completion
- 2023-09-22
- Completion
- 2023-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 5 mg | Oral |