Can a lower dose of rivaroxaban be safer for kidney patients on dialysis?

NCT ID NCT05410275

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

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

Summary

This study is testing three different low doses of the blood thinner rivaroxaban in 10 adults on chronic hemodialysis. The goal is to see how the drug behaves in the body and how much it thins the blood, to find a dose that might lower bleeding risks. Participants will take each dose for three days, and researchers will measure drug levels and clotting activity.

What this could mean

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

Active substance: rivaroxaban
What this could lead to: If successful, this could help determine a safer dose of rivaroxaban for dialysis patients who need blood thinners, potentially reducing bleeding risks.
What could go wrong: This is a very small early-phase study with only 10 participants, so results may not apply to all patients. The drug may still cause bleeding or not work as expected.

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Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

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 years and older

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: * Adult patient ≥ 18 years of age, * Chronic hemodialysis patient for at least 3 months, * Affiliated or beneficiary of a social security plan, * Having signed a written and informed consent. Exclusion Criteria: * Any indication for long-term oral anticoagulation (atrial fibrillation, venous thromboembolic disease, mechanical valve prostheses, intracardiac thrombosis, etc.) * Double anti-platelet aggregation for any reason or an aspirin dose greater than 160 mg/day * Uncontrolled hypertension (BP \> 180/110 mmHg) * Ischemic stroke within 30 days prior to inclusion * History of major unprovoked hemorrhage (leading to hospitalization or transfusion) regardless of age * Surgery within 30 days prior to inclusion * High-risk bleeding condition in addition to renal failure (such as known coagulation disorder, thrombocytopenia (\< 100G/L), active neoplasia of the digestive or urinary tract, or presence of intracranial vascular malformation) * Severe hepatic impairment * Use of strong CYP3A4 inducers, including rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital * Non-compliant patients * Pregnant or breastfeeding women, women of childbearing age without effective contraception * Contraindication to the administration of an anticoagulant treatment such as anti-phospholipid antibody syndrome * Known allergy to rivaroxaban or to one of its excipients (lactose monohydrate) * Patients under guardianship or conservatorship * Patients already participating in an ongoing study or who have participated in a study that ended less than 30 days prior to the inclusion date.

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Conditions

The condition(s) this trial relates to.

end stage renal failure kidney disorder

As listed by the trial registrant

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

Chronic hemodialysis patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a lower dose of rivaroxaban be safer for kidney patients on dialysis?

What the study statuses mean