Phase 2
N=12
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01227187 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Mean Partial Thromboplastin Time (PTT) at 15 Minutes — 38.4; 38.4; 45.4; 49.7 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Drotrecogin alfa activated (Xigris) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- George Washington University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Partial Thromboplastin Time (PTT) at 15 Minutes |
38.4; 38.4; 45.4; 49.7 | — |
| PRIMARY Mean Partial Thromboplastin Time (PTT) at 30 Minutes |
36.2; 35.7; 48.2; 51.3 | — |
| PRIMARY Mean Partial Thromboplastin Time (PTT) at 60 Minutes |
39.8; 36.4; 39.2; 52.6 | — |
| PRIMARY Mean Partial Thromboplastin Time (PTT) at 120 Minutes |
39.4; 42.8; 51.2; 54.1 | — |
| PRIMARY Mean Partial Thromboplastin Time (PTT) at 180 Minutes |
35.6; 40.9; 44.5; 52.4 | — |
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).
Eligibility Criteria
Inclusion Criteria
- >18
- Usually used heparin with HD
Exclusion Criteria
- Plt 200
- BASELINE PTT>50
- INR>1.6
Data sourced from ClinicalTrials.gov (NCT01227187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.