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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre and post doxicalciferol | Experimental | ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive will receive doxercalciferol 2 mcg or 4 mcg 3 times per week fopr 30 days (1 month). Blood work and vascular laboratory studies will be performed pre and post treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxercalciferol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endothelial Cell Function | Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jula Inrig, MD, MHS | University Texas-Southwestern | Principal Investigator |
| Lynda Szczech, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center Dialysis Unit | Durham | North Carolina | 27705 | United States |
Participants underwent review of history and meds. Hemodialysis (HD) blood was drawn. seen in vascular laboratory for testing of endothelial cell function and arterial stiffness. Doxercalciferol was initiated at dose of 2 mcg IV 3x/wk or 4 mcg IV 3x/wk. After 30 days of medication, repeat blood drawn and repeat testing in vascular laboratory.
We prospectively enrolled 24 hemodialysis patients with secondary hyperparathyroidism into an open-label 30-day observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre Doxercalciferol/Post Doxercalciferol | all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive compared pre- and post doxercalciferol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-post Comparison | ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive doxercalciferol : 2 or 4 mcg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Endothelial Cell Function | Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days. | prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism | Posted | Mean | Standard Deviation | percent change in FMD | 1 month |
|
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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 | Pre and Post Doxicalciferol | ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive doxercalciferol 2 mcg or 4 mcg three times per week for 1 month |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atypical chest pain | Cardiac disorders | Systematic Assessment | hospitalized fot atypical chest pain after consent but prior to any/all study procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| serum phosphorus 10.4 | Metabolism and nutrition disorders | Systematic Assessment | se po4 level 10.4 due to gross non compliance with phosphate binders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jula Inrig, MD | Duke University Medical Center | 919-660-6882 | Jula.Inrig@duke.edu |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051436 | Renal Insufficiency, Chronic |
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| ID | Term |
|---|---|
| C042533 | 1 alpha-hydroxyergocalciferol |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 1 |
| 20 |
| 1 |
| 20 |
|
| diabetic gastroparesis | Metabolism and nutrition disorders | Non-systematic Assessment | hospitalized for diabetic gastroparesis after study consent but prior to any/all study procedures. |
|
|
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| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |