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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of this study to examine whether vitamin D can reduce the activation of the immune system during dialysis. When activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. We want to study to what degree the immune system is activated during a regular dialysis treatment and whether the time point of vitamin D administration, either right before the start or right at the end of a dialysis treatment, has an impact on the activation of the immune system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | There is only one arm in this study. Each subject will be studied through 3 phases lasting a total of 4 weeks: Phase 1: administration of study medication at the end of hemodialysis treatment. Phase 2: no administration of study medication. Phase 3: administration of study medication at the beginning of hemodialysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol | Drug | Dosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| measurement of pro- and anti-inflammatory cytokines and inflammatory markers | first and second HD treatments for the 4 weeks of the study |
| Measure | Description | Time Frame |
|---|---|---|
| serum calcium level | 24 hours after termination of second HD treatment in week 3 of study | |
| serum phosphate level | 24 hours after termination of second HD treatment in week 3 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan W Levin, MD | Renal Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irving Place Dialysis Center | New York | New York | 10003 | United States | ||
| Upper Manhattan Dialysis Center |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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| New York |
| New York |
| 10025 |
| United States |
| Yorkville Dialysis Center | New York | New York | 10128 | United States |
| 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 |