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Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Kidney Diseases Clinical Trial

Official title:
Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00483600
Study type Interventional
Source Duke University
Contact
Status Withdrawn
Phase N/A
Start date August 2007
Completion date August 2008
View Details
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