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

This study has been completed.
Sponsor:
Collaborators:
Capital Health, Canada
Dalhousie University
Université de Montréal
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01590823
First received: April 20, 2012
Last updated: October 31, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Blood Coagulation Disorders
Drug: Dabigatran Etexilate 110 mg
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1 Study of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Pharmacokinetics following a single dose of dabigatran etexilate in hemodialysis patients. [ Time Frame: 0,0.5,1,2,3,4,12,24, and 48 hours post dose following single dabigatran dose ] [ Designated as safety issue: No ]
    Dabigatran plasma concentration following a single dose of dabigatran etexilate in hemodialysis patients


Secondary Outcome Measures:
  • Fraction of dabigatran in the blood removed by dialysis. [ Time Frame: 0,1,2,3 and 4 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dabigatran etexilate 110 mg
Single dose of Dabigatran etexilate 110 mg po
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.
Other Name: Dabigatran Etexilate 110 mg (Pradax)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients between 18 and 75 years receiving hemodialysis at the Capital District Health Authority Renal Program who are receiving or who are good candidates for normal saline flushes for prevention of extracorporeal circuit clotting will be eligible for this study.

Exclusion Criteria:

  • Of those fulfilling the inclusion criterion, the following will be excluding characteristics:

    1. know bleeding diathesis;
    2. geographic inaccessibility for follow-up of timed blood sampling;
    3. use of any anticoagulant drugs that might influence results within 48 hours of the study;
    4. history of allergy/hypersensitivity (including drug allergy) deemed relevant to the trial by the investigators;
    5. recent or planned diagnostic or therapeutic procedures with potential for bleeding within 14 days before or after drug administration;
    6. history of familial bleeding disorder;
    7. history of relevant orthostatic hypotension, fainting spells or blackouts;
    8. disease of the central nervous system (such as epilepsy);
    9. chronic or relevant acute infection; and
    10. use of medication known to potentially increase or decrease dabigtran exposure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590823

Locations
Canada, Nova Scotia
Capital Health District Authority, Department of Medicine, Division of Nephrology
Halifax, Nova Scotia, Canada, b3h 2y9
Sponsors and Collaborators
Capital District Health Authority, Canada
Capital Health, Canada
Dalhousie University
Université de Montréal
Investigators
Principal Investigator: jo-anne wilsoon, PharmD CDHA Renal Program
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01590823     History of Changes
Other Study ID Numbers: Dabigatran Hemodialysis 2012
Study First Received: April 20, 2012
Last Updated: October 31, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
pharmacokinetics

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on April 17, 2014