NCT02672709

Apixaban in Hemodialysis

Pharmacokinetics and Pharmacodynamics of Apixaban in End-stage Renal Disease Patients on Hemodialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the effects of end-stage renal disease on the pharmacokinetics, pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days. The concentration of the drug will be measured with repetitive blood tests the first and the eighth day of administration (non-dialysis days). The same blood tests will be repeated before, during, and after dialysis on dialysis days. If the study shows inadequate or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily dose.

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
DRUG	apixaban

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-02-03
• Last updated: 2016-08-30

Locations

1 site across 1 country: Canada