Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

• Status: Withdrawn
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: GlaxoSmithKline
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

• Outpatients in the Medicine and Nephrology clinics who are 18 years or older,

• Outpatients in the Medicine and Nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,

• Outpatients in the Medicine and Nephrology clinics who are able to give consent will be included.

Exclusion Criteria:

• anticoagulation therapy for thrombosis or other indication

• pregnant or breast-feeding

• hypersensitivity to fondaparinux

• subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:

• known bleeding disorder (see Section 8. Hemostatic Assessment)

• blood transfusion in the past 3 months

• acute ulcer disease with past 3 months

• platelet count < 120,000 mm3

• prolonged baseline prothrombin time (PT) or activated partial thromboplastin time (aPTT) above upper limit of normal laboratory range

• major trauma or surgery within two weeks prior to enrollment

• history of intracranial hemorrhage