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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nova Scotia Health Authority
• Collaborators: Capital Health, Canada; Dalhousie University; Université de Montréal
• Treatments: Dabigatran

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.