Dose-finding of Rivaroxaban in Hemodialysis
Chronic Renal Failure
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring Hemodialysis, Rivaroxaban, AUC
Eligibility Criteria
Inclusion Criteria:
- age ≥18 year
- signed informed consent
- chronic hemodialysis patients without immediate life-threatening conditions, dialysed three times a week for at least three months
- requiring anticoagulation for the prevention of deep venous thrombosis
Exclusion Criteria:
- residual renal function, as defined by a residual diuresis of >50 ml/day
- known intestinal malabsorption
- inability to take oral medication
- mechanical heart valve
- inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir)
- severe liver dysfunction Child-Pugh grade C
Sites / Locations
- OLV Aalst
- AZ Sint-Jan Brugge-Oostende AV
Arms of the Study
Arm 1
Experimental
Rivaroxaban 10 mg
Measurement of AUC of rivaroxaban and effect on coagulation assays: Rivaroxaban is given as a single oral dose of 10 mg immediately after three subsequent dialysis sessions. Patients remain in the hospital from the intake of the first dose until 48 hours after the intake of the third dose. Effect of dialysis on levels of rivaroxaban: Rivaroxaban is given as a single oral dose of 10 mg in the morning when dialysis is scheduled in the afternoon, or the previous evening when dialysis is scheduled in the morning. The interval between the two doses was at least 48 hours. Dialysis is scheduled 6 to 8 hours after the intake of rivaroxaban.