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Sponsors and Collaborators: |
Speedel Pharma Ltd. Quintiles |
Information provided by: | Speedel Pharma Ltd. |
ClinicalTrials.gov Identifier: | NCT00074620 |
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.
Condition | Intervention | Phase |
Chronic Kidney Failure Vascular Graft Occlusion |
Drug: PEG-hirudin |
Phase II |
MedlinePlus related topics: | Dialysis Kidney Failure |
ChemIDplus related topics: | Heparin Hirudin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Randomised, Multicenter, Open-Label, Parallel Group Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis Via an Arteriovenous Graft |
Estimated Enrollment: | 260 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | January 2006 |
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, Pennsylvania | |||||
Pennsylvania Hospital - Franklin Dialysis Center | |||||
Philadelphia, Pennsylvania, United States, 19106 |
Speedel Pharma Ltd. |
Quintiles |
Study Chair: | Jessica M Mann, MD, PhD | Speedel Bio Ltd |
Study ID Numbers: | SPP200CRD01 |
First Received: | December 17, 2003 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00074620 |
Health Authority: | United States: Food and Drug Administration |
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