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A clinical study to assess the safety of PEG-hirudin (SPP200) compared to heparin in patients who are on haemodialysis



A clinical study to assess the safety of PEG-hirudin (SPP200) compared to heparin in patients who are on haemodialysis

For Condition: Chronic Kidney Failure,Vascular Graft Occlusion
Status: Recruiting
Sponsor(s): Speedel Bio , Quintiles
Synopsis: 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 in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.
Details:
Eligibility:
Study Type:
  Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 21 Years/75 Years
Genders: Both
Protocol Entry Criteria: - 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
Total Enrollment: 260

Location and Contact Information:

Overall Study Official:
JessicaMann,  Study Chair,  Speedel Bio Ltd

The Rogosin Institute *Recruiting*
New York City,  New York,  10021
United States
Recruiting Alana  Chenault 212-746-1563


Additional Information:
Study ID Numbers:
  SPP200CRD01; 
Study Start Date: November 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074620

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