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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01121770
First received: May 6, 2010
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Renal Insufficiency
Drug: fondaparinux sodium injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Frequency of bleeding events and new thrombotic events [ Time Frame: Daily assessments will be made for bleeding and thrombosis ] [ Designated as safety issue: Yes ]
    events will be used to compare to rates in patients without renal dysfunction


Enrollment: 9
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arixtra Drug: fondaparinux sodium injection
1.5mg subcutaneously every day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121770

Locations
United States, North Carolina
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
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01121770     History of Changes
Other Study ID Numbers: Pro00021052, 112972
Study First Received: May 6, 2010
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014