"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"

Completed · Phase 1

Conditions studied: Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT01121770

Run by

Duke University

People needed

9

Starts

2010-05-01

Expected to finish

2013-02-01

Last updated by the study team

2014-09-01

Who can join

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

You may qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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