Safety and Dose Finding Study of Xigris in Hemodialysis Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: George Washington University
• Collaborator: Eli Lilly and Company
• Treatments: Drotrecogin alfa activated; Protein C

Criteria

Inclusion Criteria:

1. >18

2. Usually used heparin with HD

Exclusion Criteria:

1. Plt <100

2. Pregnancy

3. H/o bleeding diathesis

4. H/o CVA

5. Pt on Ticlid/plavix/warfarin

6. SBP >200

7. BASELINE PTT>50

8. INR>1.6