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Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Primary Purpose

Kidney Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fondaparinux
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Diseases focused on measuring Fondaparinux, Pharmacokinetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

no arms/one group

Arm Description

Outcomes

Primary Outcome Measures

PK parameters (half-life, area-under-the curve, and peak serum concentration)

Secondary Outcome Measures

Anti-factor Xa levels and assessment for bleeding(complete blood count)

Full Information

First Posted
June 5, 2007
Last Updated
July 25, 2014
Sponsor
Duke University
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00483600
Brief Title
Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction
Official Title
Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Withdrawn
Why Stopped
unable to enroll
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
Fondaparinux, Pharmacokinetic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no arms/one group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fondaparinux
Other Intervention Name(s)
Arixtra
Intervention Description
injections of 2.5mg every other day for 4 weeks
Primary Outcome Measure Information:
Title
PK parameters (half-life, area-under-the curve, and peak serum concentration)
Time Frame
after day 7 and after day 27
Secondary Outcome Measure Information:
Title
Anti-factor Xa levels and assessment for bleeding(complete blood count)
Time Frame
days 3, 13 and 19

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Ortel, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

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