Safety and Dose Finding Study of Xigris in Hemodialysis Patients

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Drotrecogin alfa activated (Xigris)

• Registration Number: NCT01227187
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-25
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Results First Submitted: 2014-02-18
• Status Verified: 2020-11
• Results First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Results First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Partial Thromboplastin Time (PTT) at 30 Minutes	PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.	PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 120 Minutes	PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.	PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 15 Minutes	PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.	PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 60 Minutes	PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.	PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Mean Partial Thromboplastin Time (PTT) at 180 Minutes	PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.	PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

Trial Locations

Locations (1)

The George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States