Status:
COMPLETED
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
Lead Sponsor:
Speedel Pharma Ltd.
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Chronic Kidney Failure
Vascular Graft Occlusion
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used...
Eligibility Criteria
Inclusion
- Patients undergoing chronic haemodialysis via an arteriovenous graft
- Arteriovenous graft in place for at least 3 months
- Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session
- Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception
- Women patients must have a negative serum pregnancy test within one week of randomisation
- Able to provide written informed consent prior to study participation
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00074620
Start Date
November 1 2003
End Date
January 1 2006
Last Update
October 5 2007
Active Locations (1)
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1
Pennsylvania Hospital - Franklin Dialysis Center
Philadelphia, Pennsylvania, United States, 19106