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Kidney dialysis patients: new study tests blood thinner safety

NCT ID NCT04006093

Knowledge-focused Sponsor: University Hospital, Caen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a single 5 mg dose of the blood thinner apixaban is processed in people with end-stage kidney disease who are on peritoneal dialysis, compared to people with normal kidney function. Researchers measured drug levels in the blood over time. The goal is to understand if dosing adjustments are needed for this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apixaban (a blood thinner)
What this could lead to
If successful, this could help doctors determine safe and effective dosing of apixaban for people on peritoneal dialysis.
What could go wrong
This is a small, early-phase study with only 24 participants, so results may not apply to everyone. It looks at drug levels, not clinical outcomes like bleeding or clotting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic renal insufficiency Peritoneal dialysis

Contacts and locations

Locations

  • CHU Caen

    Caen, 14000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.