- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00483600
Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction
July 25, 2014 updated by: Duke University
Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction
To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.
Study Overview
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: no arms/one group
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injections of 2.5mg every other day for 4 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK parameters (half-life, area-under-the curve, and peak serum concentration)
Time Frame: after day 7 and after day 27
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after day 7 and after day 27
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti-factor Xa levels and assessment for bleeding(complete blood count)
Time Frame: days 3, 13 and 19
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days 3, 13 and 19
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas L Ortel, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Study Completion (Anticipated)
August 1, 2008
Study Registration Dates
First Submitted
June 5, 2007
First Submitted That Met QC Criteria
June 5, 2007
First Posted (Estimate)
June 7, 2007
Study Record Updates
Last Update Posted (Estimate)
July 29, 2014
Last Update Submitted That Met QC Criteria
July 25, 2014
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00001571
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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