Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Not Applicable

Withdrawn

• Conditions: Kidney Diseases
• Interventions: Drug: fondaparinux

• Registration Number: NCT00483600
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-07
• Study Start: 2007-08
• Study Completion: 2008-08
• Status Verified: 2011-02
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
no arms/one group	fondaparinux	-

Primary Outcome Measures

Name	Time	Method
PK parameters (half-life, area-under-the curve, and peak serum concentration)	after day 7 and after day 27

Secondary Outcome Measures

Name	Time	Method
Anti-factor Xa levels and assessment for bleeding(complete blood count)	days 3, 13 and 19

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States