RIVAROXABAN for End-stage renal disease|Chronic hemodialysis

Inclusion criteria

• {"criterion_text":"- Adult patient ≥ 18 years\n- Chronic haemodialysis for at least 3 months\n- Participants covered by or entitled to social security\n- Patients who have signed a written informed consent form"}

Exclusion criteria

• {"criterion_text":"- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, persons subject to a legal protection measure: guardianship or trusteeship)\n- Severe hepatic insufficiency\n- Use of powerful CYP3A4 inducers (in particular rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort (Hypericum perforatum))\n- Use of treatments that inhibit CYP3A4 and gp-P, in particular azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, HIV protease inhibitors, clarithromycin and erythromycin).\n- Contraindication to anticoagulant treatment, such as anti-phospholipid antibody syndrome\n- Contraindications to the administration of rivaroxaban\n- Patient registered on the renal transplant list and refusing temporary contraindication for the duration of the study\n- Patients for whom the investigator considers that they will be unable to undergo the protocol treatment, for whatever reason\n- Patient already taking part in an ongoing study or having taken part in a study which ended less than 30 days before the inclusion date\n- Women of childbearing age not using a highly effective method of contraception for the duration of the study.\n- Any indication for long-term oral anticoagulation (atrial fibrillation, thromboembolic venous disease, mechanical valve prosthesis, intracardiac thrombosis, etc)\n- Double anti-platelet aggregation for any reason or a dose of aspirin greater than 160 mg per day\n- Uncontrolled arterial hypertension (BP > 180/110 mmHg)\n- Ischaemic stroke in the 30 days prior to inclusion\n- History of major unprovoked haemorrhage (leading to hospitalisation or transfusion), regardless of how long it has existed\n- Surgery in the 30 days prior to inclusion except for interventions considered to have a low risk of bleeding, such as dental care and extractions.\n- High-risk bleeding pathology in addition to renal failure, such as a known coagulation disorder, thrombocytopenia (< 100G/L), progressive neoplasia of the digestive or urinary tract, or the presence of an intracranial vascular malformation"}

Primary endpoints

• {"endpoint_text":"- Area under the AUC curve (drug dosage and anti-Xa activity) for each of the 3 doses of rivaroxaban (5, 10 and 15 mg/d)","definition_or_measurement_approach":"Measurement of Area Under the Curve (AUC) of drug dosage and anti-Xa activity for each rivaroxaban dose (5, 10 and 15 mg/day)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of bleeding events graded according to the BARC classification during the study period","definition_or_measurement_approach":"Bleeding events will be recorded and graded according to the BARC (Bleeding Academic Research Consortium) classification during the study period."}

France

Earliest CTIS Part Ii Submission Date

12-04-2024

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

616

Number Of Sites

2

Number Of Participants

12

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France