How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
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.
Kidney Failure, Chronic
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease|
- Change in Endothelial Cell Function [ Time Frame: 1 month ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Pre and post doxicalciferol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528788
|United States, North Carolina|
|Duke University Medical Center Dialysis Unit|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Jula Inrig, MD, MHS||University Texas-Southwestern|
|Principal Investigator:||Lynda Szczech, MD||Duke University|