An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
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.