Dose-finding of Rivaroxaban in Hemodialysis

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and treatment of thromboembolic disease. There are no data on dose adjustments in patients with severe chronic renal failure. It's use is therefore not recommended in this patient population. The present study aims to asses in 12 hemodialysis patients that require prevention of deep vein thrombosis:

1. the AUC and Cmax of 10 mg rivaroxaban

2. the effect of 10 mg rivaroxaban on coagulation assays

3. the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels

4. the safety and tolerability of rivaroxaban

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AZ Sint-Jan AV
• Collaborator: Onze Lieve Vrouw Hospital
• Treatments: Rivaroxaban

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