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An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients

NCT01590823 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-11-01

No results posted yet for this study

Summary

Patients with end stage renal disease carry a high risk for atrial fibrillation (AF) and require oral anticoagulant therapy for prevention of stroke. Often, the oral anticoagulant, warfarin sodium, is prescribed. Managing dialysis patients on warfarin can be fraught will difficulties given the multitude of drug and food interactions, need for frequent coagulation monitoring and dosage adjustment, and concern that warfarin enhances vascular calcification in dialysis patients. Recently, dabigatran etexilate, a direct oral thrombin inhibitor, has been approved for use in AF patients with normal renal function. Since many drugs are eliminated by the kidneys and removed from the plasma during dialysis, it is important to determine proper drug dosing in hemodialysis patients through evaluating pharmacokinetics.

Conditions

  • Blood Coagulation Disorders

Interventions

DRUG

Dabigatran Etexilate 110 mg

All participants will receive a single dosage of dabigatran etexilate 110 mg at the start of their 4 hour dialysis session. Blood sampling will be conducted during and up to 48 hours after participant's dialysis session.

Sponsors & Collaborators

  • Capital Health, Canada

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • jo-anne wilsoon, PharmD · CDHA Renal Program

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Canada

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 NCT01590823 on ClinicalTrials.gov