Dose-finding of Rivaroxaban in Hemodialysis

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

Timeline

Start

2013-09

Primary completion

2014-02

Completion

2014-10

Drugs

Indications