Reduced-dose rivaroxaban for end-stage renal disease patients on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional study in adults on chronic hemodialysis aiming to identify a rivaroxaban dose with the best pharmacokinetic and pharmacodynamic profile. The goal is to establish a dose that balances stroke prevention with bleeding risk in patients with end-stage renal disease who require oral anticoagulation for atrial fibrillation. The study will enroll participants meeting specific criteria and will monitor safety and pharmacology to inform a potential larger trial comparing the chosen rivaroxaban dose to standard warfarin management. Enrollment emphasizes adherence considerations given the dialysis schedule and comorbidities common in this population. The lead sponsor is University Hospital, Tours, with participation from select sites in Tours.

Why it matters

Who can join: the full rules

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.

Where it's running

• 01-Arauco
  Tours, France Recruiting
• 02-Tours
  Tours, France Recruiting

Study contacts

• Study coordinator: Fabrice IVANES, MD-PhD
• Email: F.IVANES@chu-tours.fr
• Phone: +33247473663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.