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Dose-finding of Rivaroxaban in Hemodialysis

NCT02047006 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-01-14

No results posted yet for this study

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

Conditions

  • Chronic Renal Failure

Interventions

DRUG

Rivaroxaban 10 mg

Measurement of AUC of rivaroxaban and effect on coagulation assays: Venous blood samples (8.5 ml) are collected immediately before (t=0) and at t= 0,5, 1, 2, 4, 8, 12, 24, 36 and 44 hours after administration of rivaroxaban. Effect of dialysis on levels of rivaroxaban: Venous blood samples (8.5 ml) are collected at the start of dialysis (t=0) and at t=1, 2, 3 and 4 hours.

Sponsors & Collaborators

  • Onze Lieve Vrouw Hospital

    collaborator OTHER

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • An S De Vriese, MD, PhD · AZ Sint-Lucas Brugge

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-28
Completion
2014-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02047006 on ClinicalTrials.gov