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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Cxzudi Hqetcpcnkvq Ruopkvnj Uiapcmywcazqn Df Trpvo	Notre Dame d'Oé	France
Cfvpca Hijkqglhkip Rwxwzxqc Uhdhzmovqkcxz Df Twvrj	Tours	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	08.01.2025

Trial locations

Investigated drugs:

Rivaroxaban

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.

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 ID:

2023-505733-28-00

NCT ID:

NCT05410275

Trial Phase:

Therapeutic exploratory (Phase II)

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

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