Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

This study has been withdrawn prior to enrollment.
(unable to enroll)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00483600
First received: June 5, 2007
Last updated: July 25, 2014
Last verified: February 2011
  Purpose

To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.


Condition Intervention
Kidney Diseases
Drug: fondaparinux

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • PK parameters (half-life, area-under-the curve, and peak serum concentration) [ Time Frame: after day 7 and after day 27 ]

Secondary Outcome Measures:
  • Anti-factor Xa levels and assessment for bleeding(complete blood count) [ Time Frame: days 3, 13 and 19 ]

Enrollment: 0
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
Arms Assigned Interventions
Experimental: no arms/one group Drug: fondaparinux
injections of 2.5mg every other day for 4 weeks
Other Name: Arixtra

Detailed Description:

This study will evaluate the PK of fondaparinux in patients who have renal insufficiency. Fondaparinux is cleared from the body mainly by the kidneys. Therefore in patients with kidney diseases, full doses of fondaparinux could cause bleeding problems. The correct dose of fondaparinux that should be used in patients with kidney disease is not known. The purpose of this research is to determine the PK and safety of a preventative dose (2.5mg subcutaneously every other day) of fondaparinux for patients with kidney disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients in the Medicine and Nephrology clinics who are 18 years or older,
  • Outpatients in the Medicine and Nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,
  • Outpatients in the Medicine and Nephrology clinics who are able to give consent will be included.

Exclusion Criteria:

  • anticoagulation therapy for thrombosis or other indication
  • pregnant or breast-feeding
  • hypersensitivity to fondaparinux
  • subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:

    • known bleeding disorder (see Section 8. Hemostatic Assessment)
    • blood transfusion in the past 3 months
    • acute ulcer disease with past 3 months
    • platelet count < 120,000 mm3
    • prolonged baseline prothrombin time (PT) or activated partial thromboplastin time (aPTT) above upper limit of normal laboratory range
    • major trauma or surgery within two weeks prior to enrollment
    • history of intracranial hemorrhage
  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: NCT00483600

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, PhD Duke University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00483600     History of Changes
Other Study ID Numbers: Pro00001571
Study First Received: June 5, 2007
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Fondaparinux
Pharmacokinetic

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

ClinicalTrials.gov processed this record on September 18, 2014