Apixaban in Subjects With Peritoneal Dialysis

Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study

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.

Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.

Inclusion Criteria:

• Participant with 21<BMI<40
• 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