Apixaban in Subjects With Peritoneal Dialysis

Phase 1

Completed

• Conditions: Chronic Renal Insufficiency; Peritoneal Dialysis
• Interventions: Drug: Apixaban Oral

• Registration Number: NCT04006093
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-12-08
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
participants with end-stage renal disease	Apixaban Oral	-
participants with normal renal function	Apixaban Oral	-

Primary Outcome Measures

Name	Time	Method
Apixaban maximum plasma concentration	Day 3	Measurement of apixaban plasma concentrations at different times.
Apixaban area Under the curve	Day 3	Measurement of apixaban plasma concentrations at different times.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Caen; 🇫🇷 Caen, France