"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"

Renal Insufficiency Clinical Trial

— FONDA PK  

Official title:

Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121770
• Other study ID #: Pro00021052
• Secondary ID: 112972
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2010
• Last updated: August 29, 2014
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: August 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• fondaparinux sodium injection
1.5mg subcutaneously every day

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood samples to measure specific Arixtra® concentration	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	• 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	No
Secondary	Frequency of bleeding events and new thrombotic events	events will be used to compare to rates in patients without renal dysfunction	Daily assessments will be made for bleeding and thrombosis	Yes

External Links

•   The Duke Hemostasis & Thrombosis Center provides a multidisciplinary approach to the diagnosis and management of a wide variety of hemostatic disorders and is a leader in basic research effort. Click here for more information about this study.