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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-hirudin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions. |
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| Name | Affiliation | Role |
|---|---|---|
| Jessica M Mann, MD, PhD | Speedel Bio Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Hospital - Franklin Dialysis Center | Philadelphia | Pennsylvania | 19106 | United States |
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| Label | URL |
|---|---|
| The National Kidney Foundation is a voluntary organisation which seeks to prevent kidney diseases, improve the health of patients and increase the availability of organs for transplantation | View source |
| The American Association of Kidney Patients helps kidney patients and their families deal with the physical, emotional and social impact of kidney diseases | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006083 | Graft Occlusion, Vascular |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C104614 | polyethyleneglycol-hirudin |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |