Status:
COMPLETED
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed 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 t...
Eligibility Criteria
Inclusion
- \>18
- Usually used heparin with HD
Exclusion
- Plt \<100
- Pregnancy
- H/o bleeding diathesis
- H/o CVA
- Pt on Ticlid/plavix/warfarin
- SBP \>200
- BASELINE PTT\>50
- INR\>1.6
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01227187
Start Date
October 1 2008
End Date
December 1 2010
Last Update
February 3 2022
Active Locations (1)
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1
The George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037