Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Endothelial Cell Function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 5 Chronic Kidney Disease
- •Hyperparathyroidism (PTH>300) requiring vitamin D therapy
- •Age 18-80 years old
- •Ability to provide informed consent
排除标准
- •Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy
- •Subjects with contraindications or allergy to vitamin D
- •Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days
- •Serum phosphorus > 6
- •Serum calcium > 10.5
- •contraindications to nitroglycerin (such as being on sildenafil)
研究组 & 干预措施
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.
干预措施: doxercalciferol (Drug)
结局指标
主要结局
Change in Endothelial Cell Function
时间窗: 1 month
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.
次要结局
未报告次要终点