Safety and Dose Finding Study of Xigris in Hemodialysis Patients
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | October 2008 |
| End Date: | December 2010 |
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)
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).
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.
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
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