NCT02047006

Brief 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. 1.the AUC and Cmax of 10 mg rivaroxaban
  2. 2.the effect of 10 mg rivaroxaban on coagulation assays
  3. 3.the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels
  4. 4.the safety and tolerability of rivaroxaban

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 24, 2014

Last Update Submit

January 13, 2015

Conditions

Chronic Renal Failure

Keywords

HemodialysisRivaroxabanAUC

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics and pharmacodynamics of rivaroxaban in hemodialysis patients

    1. To measure the AUC and Cmax of 10 mg rivaroxaban in hemodialysis patients 2. To assess the effect of 10 mg rivaroxaban on coagulation assays in hemodialysis patients: * anti-Xa assay * prothrombin assay

    AUC for 48 hours

Secondary Outcomes (2)

  • Dialytic removal of rivaroxaban

    4 hours

  • Safety and tolerability of rivaroxaban in hemodialysis patients

    2 weeks

Study Arms (1)

Rivaroxaban 10 mg

EXPERIMENTAL

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.

Drug: Rivaroxaban 10 mg

Interventions

Rivaroxaban 10 mgDRUG

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.

Rivaroxaban 10 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OLV Aalst

Aalst, 9300, Belgium

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • An S De Vriese, MD, PhD

    AZ Sint-Lucas Brugge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Internal Medicine

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

BE(2)