Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Anti-Inflammatory Effects of Paricalcitol
研究概览
简要总结
The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.
详细描述
We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:
Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.
The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
- •Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
- •Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
- •Hemoglobulin A1C< 11%
排除标准
- •Patients taking vitamin D analogs
- •Calcium> 10 mg/dL
- •Phosphorus>6 mg/dL
- •Patients with anticipated need of dialysis in the next 6 weeks
- •Patients unstable in the opinion of the investigator
- •Patients who have emergent need for starting IV iron
- •Patients who will be started on statins within the next 6 weeks
- •Patients currently taking PDE5 inhibitors
- •Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
- •Patients known to be HIV positive
- •Patients who can not give informed consent
研究组 & 干预措施
1
1 mcg paricalcitol
干预措施: paricalcitol (Drug)
2
2 mcg paricalcitol
干预措施: paricalcitol (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Anti-Inflammatory Effects of Paricalcitol
时间窗: 6 weeks
change in hsCRP level from baseline to 4 weeks
Endothelial Protectant Effects of Paricalcitol
时间窗: 6 weeks
次要结局
- Effect of Paricalcitol on Hypertension(6 weeks)
- Effect of Paricalcitol on Kidney Function(6 weeks)