How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
This study has been completed.
Sponsor:
Duke University
Collaborator:
Genzyme
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00528788
First received: September 10, 2007
Last updated: August 6, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 10, 2007 | ||||||||
| Last Updated Date | August 6, 2012 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
change in endothelial cell function [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
change in endothelial cell function [ Time Frame: 1 month ] | ||||||||
| Change History | Complete list of historical versions of study NCT00528788 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis | ||||||||
| Official Title ICMJE | Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease | ||||||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: doxercalciferol
Please contact PI. |
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| Study Arm (s) | Experimental: Pre-post comparison
ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive
Intervention: Drug: doxercalciferol |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | August 2012 | ||||||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00528788 | ||||||||
| Other Study ID Numbers ICMJE | pro00001559 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Duke University | ||||||||
| Study Sponsor ICMJE | Duke University | ||||||||
| Collaborators ICMJE | Genzyme | ||||||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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