Safety and Dose Finding Study of Xigris in Hemodialysis Patients (Xigris1003)

George Washington University (GW)

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Drotrecogin alfa activated (Xigris)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01227187

F1K-MC-1003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Xigris

Experimental group

Description:

Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis.

Treatment:

Drug: Drotrecogin alfa activated (Xigris)