Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Withdrawn before enrolling · Not applicable

Conditions studied: Kidney Diseases

In brief

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

Key facts

Study ID

NCT00483600

Run by

Duke University

People needed

0

Starts

2007-08-01

Expected to finish

2008-08-01

Last updated by the study team

2014-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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