Chronic Renal Insufficiency, Peritoneal Dialysis
Conditions
Brief 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.
Detailed description
Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.
Interventions
DRUGApixaban single dose 5mg
Apixaban oral single dose 5mg
Sponsors
University Hospital, Caen
University Hospital, Rouen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apixaban area Under the curve | Day 3 | Measurement of apixaban plasma concentrations at different times. |
| Apixaban maximum plasma concentration | Day 3 | Measurement of apixaban plasma concentrations at different times. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-Xa activity | Hour 0, Hour 3, Hour 9 and Hour 72 | anti-Xa activity plasma measurements |
| TP activity | Hour 0, Hour 3, Hour 9 and Hour 72 | TP activity plasma measurements |
| TCA activity | Hour 0, Hour 3, Hour 9 and Hour 72 | TCA activity plasma measurements |
| Apixaban urinary elimination | Day 3 | Measurement of apixaban urinary concentrations |
| Apixaban maximum peritoneal concentration | day 3 | Measurement of apixaban peritoneal fluid concentrations |
Countries
France
Outcome results
None listed