"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction" (FONDA PK)

Duke University

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: fondaparinux sodium injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01121770

Pro00021052

112972

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Arixtra

Experimental group

Treatment:

Drug: fondaparinux sodium injection