"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Inpatients who are 18 years or older

• estimated creatinine clearances between 20-50 ml/min

• current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery

• able to give informed consent

• need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode

Exclusion Criteria: Use of the following

• clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)

• body weight < 50 kg

• anticoagulation therapy for thrombosis or other indication

• pregnant or breast-feeding

• hypersensitivity to Arixtra®

• thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra®

• bacterial endocarditis

• brain malignancy

• increased risk of bleeding.