"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | May 2010 |
| End Date: | February 2012 |
| Contact: | Patrick A Jordan, BS |
| Email: | patrick.jordan@duke.edu |
| Phone: | 919-681-2668 |
Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
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.
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.
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