Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Rivaroxaban for Patients with End-Stage Renal Disease on Hemodialysis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called rivaroxaban, which is used to prevent blood clots, in patients with end-stage renal disease who are undergoing chronic hemodialysis. Hemodialysis is a treatment that filters and purifies the blood using a machine, which is necessary when the kidneys are not functioning properly. The study aims to find the safest and most effective dose of rivaroxaban for these patients, who do not have a current need for oral anticoagulation, which is a treatment to prevent blood clots.

Participants in the study will receive one of three different daily doses of rivaroxaban: 5 mg, 10 mg, or 15 mg. The study will monitor how the body processes the medication and its effects on the blood, which is referred to as pharmacokinetics and pharmacodynamics. The study will also observe any bleeding events that may occur during the trial period, as bleeding is a potential side effect of anticoagulant medications.

The purpose of this study is to identify the dose of rivaroxaban that provides the best balance of safety and effectiveness for patients with end-stage renal disease on chronic hemodialysis. The trial is expected to run until April 2025, with recruitment starting in April 2024. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the medication's effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing a written informed consent form. Eligibility requires being an adult aged 18 or older, undergoing chronic hemodialysis for at least three months, and having social security coverage.

  2. Step 2

    Medication administration

    The medication used in the study is Xarelto, which contains the active substance rivaroxaban. It is administered in the form of a film-coated tablet taken orally.

    The study aims to identify the best dose of rivaroxaban for safety and effectiveness. The doses being tested are 5 mg, 10 mg, and 15 mg per day.

  3. Step 3

    Monitoring and evaluation

    The primary focus is on measuring the area under the curve (AUC) for drug dosage and anti-Xa activity for each dose of rivaroxaban. This helps in understanding how the drug is processed in the body.

    Secondary evaluations include monitoring for any bleeding events, which are classified according to the BARC classification system.

  4. Step 4

    Study duration

    The study is expected to start recruiting participants on April 1, 2024, and is estimated to conclude by April 1, 2025.

Who can join the trial?

4 criteria

  • Must be an adult who is 18 years or older.
  • Must have been on chronic hemodialysis for at least 3 months. Hemodialysis is a treatment that helps clean the blood when the kidneys are not working well.
  • Must be covered by or entitled to social security, which means having access to government health benefits.
  • Must have signed a written informed consent form, which is a document that explains the study and confirms the participant agrees to take part.

Who cannot join the trial?

4 criteria

  • Patients who are not on chronic hemodialysis cannot participate. Chronic hemodialysis is a treatment for kidney failure that uses a machine to filter waste and water from the blood.
  • Patients who have a medical reason to take oral anticoagulation cannot participate. Oral anticoagulation refers to medications taken by mouth to prevent blood clots.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who belong to a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Rivaroxaban is a medication used to prevent blood clots. In this clinical trial, it is being studied to find the best dose for patients with end-stage kidney disease who are on dialysis. The goal is to determine which dose provides the best balance between safety and effectiveness in preventing clots without causing excessive bleeding.

What is already known about the treatment

Rivaroxaban – Rivaroxaban is an oral medication administered in tablet form, primarily used as an anticoagulant to prevent blood clots. It is currently being studied in clinical trials for its effectiveness and safety in patients undergoing chronic hemodialysis. The main therapeutic indication for rivaroxaban is to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as to treat and prevent deep vein thrombosis and pulmonary embolism. At the molecular level, rivaroxaban works by inhibiting Factor Xa, an essential component in the blood coagulation process, thereby reducing the formation of clots. It is classified pharmacologically as a direct oral anticoagulant (DOAC).

Investigated diseases

Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This can lead to a buildup of harmful substances in the body, causing symptoms like fatigue, swelling, and changes in urination. Over time, the disease can progress to more severe stages, potentially requiring treatments like dialysis to perform the kidneys' functions. Chronic hemodialysis is a treatment used in advanced stages, where a machine filters the blood outside the body. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function. Regular monitoring and lifestyle adjustments are often necessary to manage the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505733-28-00Estimated enrolment12 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.