Apixaban in Subjects With Peritoneal Dialysis (ApiDP)

Caen University Hospital

Status and phase

Completed

Phase 1

Conditions

Peritoneal Dialysis

Chronic Renal Insufficiency

Treatments

Drug: Apixaban Oral

Study type

Interventional

Funder types

Other

Identifiers

NCT04006093

19-060

Details and patient eligibility

About

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.

Full description

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

Enrollment

24 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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