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

Status

Withdrawn

Conditions

Intervention / Treatment

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

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
Experimental: no arms/one group
Drug: fondaparinux
injections of 2.5mg every other day for 4 weeks
Other Names:
  • Arixtra

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
after day 7 and after day 27

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
days 3, 13 and 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

GlaxoSmithKline

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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