"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"

Phase 1

Completed

• Conditions: Renal Insufficiency
• Interventions: Drug: fondaparinux sodium injection

• Registration Number: NCT01121770
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Primary Completion: 2012-10
• Study Completion: 2013-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arixtra	fondaparinux sodium injection	-

Primary Outcome Measures

Name	Time	Method
Blood samples to measure specific Arixtra® concentration	• Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra	peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose

Secondary Outcome Measures

Name	Time	Method
Frequency of bleeding events and new thrombotic events	Daily assessments will be made for bleeding and thrombosis	events will be used to compare to rates in patients without renal dysfunction

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States