Apixaban in Subjects With Peritoneal Dialysis

NCT ID: NCT04006093

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-08

Study Completion Date

2022-12-10

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.

Conditions

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Chronic Renal Insufficiency Peritoneal Dialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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participants with normal renal function

Group Type EXPERIMENTAL

Apixaban Oral

Intervention Type DRUG

one Tablet 5mg

participants with end-stage renal disease

Group Type EXPERIMENTAL

Apixaban Oral

Intervention Type DRUG

one Tablet 5mg

Interventions

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Apixaban Oral

one Tablet 5mg

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Caen

Caen, , France

Site Status

Countries

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France

Other Identifiers

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19-060

Identifier Type: -

Identifier Source: org_study_id

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