Chronic Hemodialysis PatientsPhase 3CARD-AXANCT05410275
Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients
A Phase 3 study testing Rivaroxaban in people with Chronic Hemodialysis Patients, run by University Hospital, Tours at 2 sites in France.
Trial summary
Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy according to the risk of embolic events assessed by risk scores such as the CHA2DS2-Vasc score, but this prescription is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hemodialysis Patients
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jan 2025to 30 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
01-Arauco
Tours
Annabelle GOUMARD, 02 47 47 72 63, a.goumard@arauco.fr
- Recruiting
02-TOURS
Tours
Jean-François VALENTIN, 02 47 47 37 78, jf.valentin@chu-tours.fr
About this study
Official title: Chronic Anticoagulation in End-stage Renal Disease Patients: Pharmacokinetics and Pharmacodynamic of a Reduced Dose Regimen of Rivaroxaban
Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy according to the risk of embolic events assessed by risk scores such as the CHA2DS2-Vasc score, but this prescription is associated with a risk of hemorrhagic events that must be taken into consideration when deciding on the treatment for a given patient. There are two categories of validated oral anticoagulant treatments for the prevention of embolic events in atrial fibrillation: antivitamin K agents, which have long been the reference treatment but are restrictive and difficult to use because of a narrow therapeutic window, and direct oral anticoagulants, which are now the first-line treatment but have not been evaluated in phase II and III studies in patients with severe renal failure. End-stage renal disease (clearance <15 mL/min/1.73m2), particularly at the dialysis stage, is a risk factor for cardiovascular disease in its own right, and a significant number of patients develop atrial fibrillation. Given the co-morbidities associated with renal failure, in particular hypertension, patients with renal failure undergoing dialysis and suffering from atrial fibrillation are generally at a higher risk of embolism than patients without renal failure, but also at a higher risk of bleeding. Thus, if the indication for prescribing oral anticoagulant therapy is clear in this population, the associated bleeding complications are also more frequent and more serious in these patients who have regular vascular accesses in the context of hemodialysis. There is thus a real need for reliable therapeutic alternatives with a better benefit/risk ratio than antivitamins K.
Translated with www.DeepL.com/Translator (free version)
Read the detailed description
Chronic dialysis patients are a special population because the constraints linked to their disease (3 dialyses per week) make them a captive population that nephrologists know perfectly well. If the identification of the subjects to be included does not pose any problem, it is more their adherence to the project which is likely to be more difficult because it implies additional constraints in these patients with potentially many comorbidities.
This proof-of-concept study will identify the dose of rivaroxaban with the best pharmacokinetic/ pharmacodynamic profile in chronic hemodialysis patients. It will then be possible to envisage a larger study of the type of a national Hospital Clinical Research Program (PHRC) in order to evaluate the dose of rivaroxaban chosen in hemodialysis patients with atrial fibrillation with an indication for oral anticoagulation on the basis of morbidity-mortality criteria in comparison with treatment with antivitamins K that is well conducted.
- Conditions
- Chronic Hemodialysis Patients
- Being tested
- Rivaroxaban
- Keywords
- Kidney Diseases, Therapeutic drug monitoring
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Experimental group Each patient will receive successively over 3 distinct periods the 3 doses of rivaroxaban to be evaluated, i.e., 5 mg, 10 mg, and 15 mg as a single daily dose (once daily over 3 days for each dose).
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Rivaroxaban 5 mg daily, administered orally, during 3 consecutive days. After a wash-out period of 4 days, Rivaroxaban 10 mg daily, administered orally, during 3 consecutive days.
After a wash-out period of 4 days, Rivaroxaban 15 mg daily, administered orally, during 3 consecutive days. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Plasma anti-Xa activity assessment (international unit per milliliter, IU/mL) on serial blood sampling at specified time points
Measured: 1 month
Pharmacokinetics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Direct measurement of Rivaroxaban plasma level (nanogram per milliliter, ng/mL) on serial blood sampling at specified time points
Measured: 1 month
Secondary outcomes (1)
Hemorrhagic risk assessment of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Every bleeding event will be reported and classified according to the BARC classification
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start8 Jan 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice IVANES, MD-PhD, Study director, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410275
- Sponsor's protocol ID
- DR190242-CARD-AXA
- Acronym
- CARD-AXA
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Anticoagulation in End-stage Renal Disease Patients: Pharmacokinetics and Pharmacodynamic of a Reduced Dose Regimen of Rivaroxaban
- ClinicalTrials.gov ID
- NCT05410275
- Acronym / sponsor ID
- CARD-AXA / DR190242-CARD-AXA
- Conditions
- Chronic Hemodialysis Patients
- Keywords
- Kidney Diseases, Therapeutic drug monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy according to the risk of embolic events assessed by risk scores such as the CHA2DS2-Vasc score, but this prescription is associated with a risk of hemorrhagic events that must be taken into consideration when deciding on the treatment for a given patient. There are two categories of validated oral anticoagulant treatments for the prevention of embolic events in atrial fibrillation: antivitamin K agents, which have long been the reference treatment but are restrictive and difficult to use because of a narrow therapeutic window, and direct oral anticoagulants, which are now the first-line treatment but have not been evaluated in phase II and III studies in patients with severe renal failure. End-stage renal disease (clearance <15 mL/min/1.73m2), particularly at the dialysis stage, is a risk factor for cardiovascular disease in its own right, and a significant number of patients develop atrial fibrillation. Given the co-morbidities associated with renal failure, in particular hypertension, patients with renal failure undergoing dialysis and suffering from atrial fibrillation are generally at a higher risk of embolism than patients without renal failure, but also at a higher risk of bleeding. Thus, if the indication for prescribing oral anticoagulant therapy is clear in this population, the associated bleeding complications are also more frequent and more serious in these patients who have regular vascular accesses in the context of hemodialysis. There is thus a real need for reliable therapeutic alternatives with a better benefit/risk ratio than antivitamins K.
Translated with www.DeepL.com/Translator (free version)
Detailed description
Chronic dialysis patients are a special population because the constraints linked to their disease (3 dialyses per week) make them a captive population that nephrologists know perfectly well. If the identification of the subjects to be included does not pose any problem, it is more their adherence to the project which is likely to be more difficult because it implies additional constraints in these patients with potentially many comorbidities.
This proof-of-concept study will identify the dose of rivaroxaban with the best pharmacokinetic/ pharmacodynamic profile in chronic hemodialysis patients. It will then be possible to envisage a larger study of the type of a national Hospital Clinical Research Program (PHRC) in order to evaluate the dose of rivaroxaban chosen in hemodialysis patients with atrial fibrillation with an indication for oral anticoagulation on the basis of morbidity-mortality criteria in comparison with treatment with antivitamins K that is well conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanRivaroxaban 5 mg daily, administered orally, during 3 consecutive days. After a wash-out period of 4 days, Rivaroxaban 10 mg daily, administered orally, during 3 consecutive days. After a wash-out period of 4 days, Rivaroxaban 15 mg daily, administered orally, during 3 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanExperimental group Each patient will receive successively over 3 distinct periods the 3 doses of rivaroxaban to be evaluated, i.e., 5 mg, 10 mg, and 15 mg as a single daily dose (once daily over 3 days for each dose). | Drug | Rivaroxaban |
Primary outcome
Pharmacodynamics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Time frame: 1 month
Plasma anti-Xa activity assessment (international unit per milliliter, IU/mL) on serial blood sampling at specified time points
Pharmacokinetics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Time frame: 1 month
Direct measurement of Rivaroxaban plasma level (nanogram per milliliter, ng/mL) on serial blood sampling at specified time points
1 secondary outcome
Hemorrhagic risk assessment of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice IVANES, MD-PhD study director
University Hospital of TOURS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban in people with Chronic Hemodialysis Patients, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice IVANES, MD-PhD (+33247473663, F.IVANES@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.