Study Results
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2019-12-08
2022-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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participants with normal renal function
Apixaban Oral
one Tablet 5mg
participants with end-stage renal disease
Apixaban Oral
one Tablet 5mg
Interventions
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Apixaban Oral
one Tablet 5mg
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
University Hospital, Caen
OTHER
Responsible Party
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Locations
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CHU Caen
Caen, , France
Countries
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Other Identifiers
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19-060
Identifier Type: -
Identifier Source: org_study_id
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