NCT00483600

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 29, 2014

Status Verified

February 1, 2011

First QC Date

June 5, 2007

Last Update Submit

July 25, 2014

Conditions

Kidney Diseases

Keywords

FondaparinuxPharmacokinetic

Outcome Measures

Primary Outcomes (1)

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

    after day 7 and after day 27

Secondary Outcomes (1)

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

    days 3, 13 and 19

Study Arms (1)

no arms/one group

EXPERIMENTAL
Drug: fondaparinux

Interventions

fondaparinuxDRUG

injections of 2.5mg every other day for 4 weeks

Also known as: Arixtra
no arms/one group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Thomas L Ortel, PhD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2007

First Posted

June 7, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2008

Last Updated

July 29, 2014

Record last verified: 2011-02

Locations

US(1)