Clinical trial NCT01227187: Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Anticoagulation
Xigris
PTT
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2010-10-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Mean Partial Thromboplastin Time (PTT) at 15 Minutes
timeFrame: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.
measure: Mean Partial Thromboplastin Time (PTT) at 30 Minutes
timeFrame: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.
measure: Mean Partial Thromboplastin Time (PTT) at 60 Minutes
timeFrame: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.
measure: Mean Partial Thromboplastin Time (PTT) at 120 Minutes
timeFrame: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.
measure: Mean Partial Thromboplastin Time (PTT) at 180 Minutes
timeFrame: PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University Hospital
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Lakhmir S Chawla, MD
role: PRINCIPAL_INVESTIGATOR
References:
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