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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01121770
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 33.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency	Drug: fondaparinux sodium injection	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arixtra	Drug: fondaparinux sodium injection; 1.5mg subcutaneously every day

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• GlaxoSmithKline

Investigators

• Principal Investigator: Thomas L Ortel, M.D, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01121770
• Other Study ID Numbers: Pro00021052; 112972
• First Posted: May 12, 2010
• Last Update Posted: Sep 1, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Renal Insufficiency; PENTA; Fondaparinux

Study Results

No Results Posted as of Sep 1, 2014