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| Name | Class |
|---|---|
| Albany College of Pharmacy and Health Sciences | OTHER |
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This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | paricalcitol 1 mcg QD x 8 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56 | Day 28 and Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
History of any of the following diseases:
Currently taking any vitamin D products
Mean systolic blood pressure values > 190 or diastolic blood pressure values > 100 mm/Hg during the preceding 30 day period prior to screening
Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P > 55 mg2/dL2
Currently receiving erythropoiesis stimulating agent or intravenous iron therapy
Pregnant or breastfeeding
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| Name | Affiliation | Role |
|---|---|---|
| Amy Pai, Pharm.D. | Albany College of Pharmacy and Health Sciences | Principal Investigator |
| Amy Pai, PharmD | Albany College of Pharmacy and Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center South Clinical Campus | Albany | New York | 12208 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol | Paricalcitol: paricalcitol 1 mcg QD x 8 weeks |
| FG001 | Placebo | Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One placebo group patient dropped out due to an adverse event is not included in baseline measures or in outcome measures. Assuming 35% variability in circulating ICAM-1 concentrations,46 a sample size of 18 per group is adequate to detect a 50 percentage point difference in the percent in ICAM-1 with 80% power and an = 0.05.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks |
| BG001 | Paricalcitol | Paricalcitol: paricalcitol 1 mcg QD x 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56 | Posted | Mean | Standard Deviation | nanogram/ml | Day 28 and Day 56 |
|
|
TENTATIVE: 7 weeks of intervention and 30 days of followup, totalling up to 12 weeks per person
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness | Nervous system disorders | Systematic Assessment | Patient took one dose of placebo and complained of weakness. The study drug was stopped and the dose of gabapentin the patient was taking was higher than recommended for his renal function which was addressed by the attending physician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Pai | University of Michigan | 7346470005 | amypai@med.umich.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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| Drug |
Placebo for Paricalcitol 1 mcg QD x 8 weeks |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| estimated glomerular filtration rate | Mean | Standard Deviation | mL/min/1.73m2 |
|
| Counts |
|---|
| Participants |
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Paricalcitol | Paricalcitol: paricalcitol 1 mcg QD x 8 weeks | 0 | 20 | 0 | 20 |
|
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| 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 |