Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
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).
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.
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