Apixaban in Subjects With Peritoneal Dialysis

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

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

Conditions
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Chronic Renal Insufficiency, Peritoneal Dialysis

Intervention / Treatment
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* Drug: Apixaban Oral


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants with normal renal function<br> | Drug: Apixaban Oral<br>* one Tablet 5mg<br>|
| Experimental: participants with end-stage renal disease<br> | Drug: Apixaban Oral<br>* one Tablet 5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apixaban area Under the curve | Measurement of apixaban plasma concentrations at different times. | Day 3 | 
| Apixaban maximum plasma concentration | Measurement of apixaban plasma concentrations at different times. | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-Xa activity | anti-Xa activity plasma measurements | Hour 0, Hour 3, Hour 9 and Hour 72 | 
| TP activity | TP activity plasma measurements | Hour 0, Hour 3, Hour 9 and Hour 72 | 
| TCA activity | TCA activity plasma measurements | Hour 0, Hour 3, Hour 9 and Hour 72 | 
| Apixaban urinary elimination | Measurement of apixaban urinary concentrations | Day 3 | 
| Apixaban maximum peritoneal concentration | Measurement of apixaban peritoneal fluid concentrations | day 3 |