Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction - Full Text View

Sponsors and Collaborators:	Duke University GlaxoSmithKline
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00483600

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

Drug Information available for: Fondaparinux sodium ORG 31540

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction

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 ]

Estimated Enrollment:	12
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
no arms/one group: Experimental	Drug: fondaparinux injections of 2.5mg every other day for 4 weeks

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483600

Contacts

Contact: Mary A Gleim, AS, MLT

919-681-6159

gleim001@mc.duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Stephanie L Perry, MD 919-684-5350 perry052@mc.duke.edu

Sponsors and Collaborators

Duke University

GlaxoSmithKline

Investigators

Principal Investigator:

Thomas L Ortel, PhD

Duke University

More Information

Study ID Numbers:	Pro00001571
Study First Received:	June 5, 2007
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00483600
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Fondaparinux
Pharmacokinetic

Study placed in the following topic categories:

Urologic Diseases
Fondaparinux
Kidney Diseases
Org 31540

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009