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Safety and Dose Finding Study of Xigris in Hemodialysis Patients — Xigris1003  

End Stage Renal Disease Clinical Trial

Official title:
Safety and Dose Finding Study of Xigris (Drotrecogin Alfa Activated) as an Anti-coagulant in End Stage Renal Disease (ESRD) Patients Treated With Hemodialysis (HD)

Clinical Trial Summary

The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

Clinical Trial Description

In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%). Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01227187
Study type Interventional
Source George Washington University
Contact
Status Completed
Phase Phase 2
Start date October 2008
Completion date December 2010
View Details
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