跳至主要内容
临床试验/NCT02372695
NCT02372695终止4 期

Effect of Paricalcitol Over Vessel Wall: Pleiotropic Analogues Vitamin D Effects

Effice Servicios Para la Investigacion S.L.0 个研究点目标入组 50 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
50
主要终点
Prevention on vessels progression based on paricalcitol intake.

研究概览

简要总结

To provide evidence based prospectives of the potential benefit effects of paricalcitol, an analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

详细描述

Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 50 and 75 years.
  • Chronic kidney disease stage 5 D or 4-5 No D as calculated glomerular filtration rate (MDRD).
  • Concentration of intact parathyroid hormone (iPTH): 150-400 pg/ml.
  • Plasma concentrations of 25 (OH) vitamin D <30 ng/ml.
  • Without vitamin D supplementation for 3 months before the study.
  • Serum P> 3.8 mg / dl.
  • Serum Ca> 9.8 mg / dl.
  • No history of cardiovascular events (angina or myocardial infarction, stroke, peripheral arterial disease).
  • No exclusion criteria for the use of contrast.

排除标准

  • Allergic reaction to sulfur hexafluoride.
  • Recent unstable cardiac symptoms.
  • Patients with recent coronary intervention (<7 days)
  • Patients with class III and IV heart failure or severe arrhythmias.
  • Severe pulmonary hypertension.

研究组 & 干预措施

Treatment

Experimental

Patient will take one pill of paricalcitol a day.

干预措施: Paricalcitol (Drug)

结局指标

主要结局

Prevention on vessels progression based on paricalcitol intake.

时间窗: participants will be followed for the duration of whole study, an expected average of 1 year

Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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