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A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04278729
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase Phase 1
Start date April 14, 2021
Completion date September 22, 2023
View Details
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