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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590823
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : November 1, 2012
Capital Health, Canada
Dalhousie University
Université de Montréal
Information provided by (Responsible Party):
Nova Scotia Health Authority

Brief 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.

Condition or disease Intervention/treatment Phase
Blood Coagulation Disorders Drug: Dabigatran Etexilate 110 mg Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 Study of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]
    Dabigatran plasma concentration following a single dose of dabigatran etexilate in hemodialysis patients

Secondary Outcome Measures :
  1. Fraction of dabigatran in the blood removed by dialysis. [ Time Frame: 0,1,2,3 and 4 hours post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590823

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nova Scotia Health Authority Identifier: NCT01590823     History of Changes
Other Study ID Numbers: Dabigatran Hemodialysis 2012
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: April 2012
Keywords provided by Nova Scotia Health Authority:
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action