Apixaban in Subjects With Peritoneal Dialysis

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Collaborator: University Hospital, Rouen
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• Participant with 21- French participant

• Participant able to consent

• Participant with social insurance

• Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated

Exclusion Criteria:

• Participant with hypersensibility reactions to apixaban

• Participant with a history of major bleeding

• Participant already on anticoagulant

• Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage > 300 mg

• Participant on potent inhibitors of CYP 3A4 and P-gp

• Participant on inducers of CYP3A4 and P-sp

• Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

• Participant receiving or having received antibiotic treatment within 14 days prior to study

• Pregnant or lactating women

• Participant with known hypersensitivity reactions to icodextrin

• Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)

• Participant with "Normal renal function" with glomerular filtration rate < 90 ml/min