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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121770
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: fondaparinux sodium injection Phase 1

Study Type : Interventional  (Clinical Trial)
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 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Blood samples to measure specific Arixtra® concentration [ Time Frame: • 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 [ Time Frame: Daily assessments will be made for bleeding and thrombosis ]
    events will be used to compare to rates in patients without renal dysfunction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121770

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Thomas L Ortel, M.D, PhD Duke University

Additional Information:
Responsible Party: Duke University Identifier: NCT01121770     History of Changes
Other Study ID Numbers: Pro00021052
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents