A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
ACCP Research Institute American College of Clinical Pharmacy