CompletedPhase 1

Apixaban in Subjects With Peritoneal Dialysis

France24 participantsStarted 2019-12-08

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Apixaban area Under the curve

Timeframe: Day 3

Apixaban maximum plasma concentration

Timeframe: Day 3

Trial details

NCT IDNCT04006093

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-10

View on ClinicalTrials.gov More Chronic Renal Insufficiency trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.