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| ID | Type | Description | Link |
|---|---|---|---|
| 112972 |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arixtra | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fondaparinux sodium injection | Drug | 1.5mg subcutaneously every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples to measure specific Arixtra® concentration | peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose | • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of bleeding events and new thrombotic events | events will be used to compare to rates in patients without renal dysfunction | Daily assessments will be made for bleeding and thrombosis |
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Inclusion Criteria:
Exclusion Criteria: Use of the following
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| Name | Affiliation | Role |
|---|---|---|
| Thomas L Ortel, M.D, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| The Duke Hemostasis \& Thrombosis Center provides a multidisciplinary approach to the diagnosis and management of a wide variety of hemostatic disorders and is a leader in basic research effort. Click here for more information about this study. | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |