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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Vitamin D use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for involvement of the vitamin D receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.
Patients with ESRD have a high incidence of acute phase inflammation. Studies have shown that C-reactive Protein (CRP) and interleukin-6 (IL-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. Both uremia and the dialysis process itself contribute to this inflammatory state. It is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Receive Paricalcitol |
|
| B | No Intervention | Paricalcitol on hold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome is a significant change in markers of inflammation to include: | 4 weeks | |
| CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark R Kaplan, M.D. | Fresenius Medical Care North America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Nephrology | Evergreen Park | Illinois | 60805 | United States | ||
| Nephrology Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 26, 2015 | |
| Reset | Sep 24, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 26, 2015 | Sep 24, 2015 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| 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 |
|---|---|
| C084656 | paricalcitol |
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| Kalamazoo |
| Michigan |
| 49007 |
| United States |
| Nephrology Associates P.A. | West Orange | New Jersey | 07052 | United States |
| Delaware Valley Nephrology | Philadelphia | Pennsylvania | 19144 | United States |
| Nephrology Associates, PC | Nashville | Tennessee | 37205 | United States |
| Tyler Nephrology Associates | Tyler | Texas | 75701 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |