Chronic anticoagulation in end-stage renal disease patients: pharmacocinetics and pharmacodynamic of a reduced dose regimen of rivaroxaban (CARD-AXA)

Centre Hospitalier Regional Universitaire De Tours0 sites10 target enrollmentDecember 22, 2023

ConditionsChronic hemodialysis MedDRA version: 21.1Level: LLTClassification code: 10066622Term: Chronic hemodialysis Class: 10042613 Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic hemodialysis
Sponsor: Centre Hospitalier Regional Universitaire De Tours
Enrollment: 10
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 22, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Eligibility Criteria

Inclusion Criteria

•Adult patient \= 18 years, Chronic haemodialysis for at least 3 months, Participants covered by or entitled to social security, Patients who have signed a written informed consent form

Exclusion Criteria

•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), Severe hepatic insufficiency, Use of powerful CYP3A4 inducers (in particular rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort (Hypericum perforatum)), Use of treatments that inhibit CYP3A4 and gp\-P, in particular azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, HIV protease inhibitors, clarithromycin and erythromycin)., Contraindication to anticoagulant treatment, such as anti\-phospholipid antibody syndrome, Contraindications to the administration of rivaroxaban, Patient registered on the renal transplant list and refusing temporary contraindication for the duration of the study, Patients for whom the investigator considers that they will be unable to undergo the protocol treatment, for whatever reason, 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, Women of childbearing age not using a highly effective method of contraception for the duration of the study., Any indication for long\-term oral anticoagulation (atrial fibrillation, thromboembolic venous disease, mechanical valve prosthesis, intracardiac thrombosis, etc), Double anti\-platelet aggregation for any reason or a dose of aspirin greater than 160 mg per day, Uncontrolled arterial hypertension (BP \> 180/110 mmHg), Ischaemic stroke in the 30 days prior to inclusion, History of major unprovoked haemorrhage (leading to hospitalisation or transfusion), regardless of how long it has existed, Surgery in the 30 days prior to inclusion, 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