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临床试验/NCT02672293
NCT02672293已完成不适用

Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Dr. Rachel Holden1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
Fractional excretion of phosphate

研究概览

简要总结

Over 20 million people in North America (including 2 million Canadians) have chronic kidney disease. These individuals die from diseases of the heart and blood vessels more often than they need dialysis. This is due to hardening of the arteries caused by calcium deposits inside the blood vessel walls. These deposits damage the vessels, causing them to lose flexibility. This makes them unable to respond to the changing demands of the body, and eventually leads to blockages such as stroke and ultimately death.

High levels of phosphate in the blood have been consistently linked to the development of calcium deposits inside blood vessel walls. The kidney is the only organ in the body that can eliminate phosphate that is not required by the body. As kidney function becomes worse, body levels of phosphate increase. However, investigators do not know the time point in the course of kidney disease that problems begin in the way phosphate is eliminated into the urine by the kidneys. Investigators will test the response of the kidneys to a phosphate challenge taken by mouth in subjects who are having accurate measures of kidney function performed by a method called 'inulin clearance'.

The investigators believe that the results of this study will provide important information identifying when investigators should be concerned about body levels of phosphate increasing. This information may lead to changes in the way investigators treat patients by reducing the levels of phosphate in the diet at a much earlier time point then is presently recommended.

详细描述

Fractional excretion of phosphate will be measured pre- and 60 minutes and 120 minutes following an oral challenge of 500 mg of oral phosphate in a group of patients with gold standard measures of glomerular filtration rate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • stable chronic kidney disease

排除标准

  • unable/unwilling to give informed consent;
  • pregnant or breast-feeding;
  • known allergy to shellfish, iodine or inulin;
  • have evidence of impaired bladder emptying defined as a post-void residual of greater than 20 ml.

研究组 & 干预措施

Phosphate

Experimental

500 mg of oral phosphate is administered after an overnight fast.

干预措施: Phoslax (Drug)

结局指标

主要结局

Fractional excretion of phosphate

时间窗: Change in fractional excretion of phosphate at 1 and 2 hours

Fractional excretion of phosphate will be measured at baseline and at 1 and 2 hours following a standardized oral phosphate challenge

次要结局

  • Fibroblast growth factor-23(Change in level of fibroblast growth factor 23 at 2 hours)
  • Vitamin D(Change in level of vitamin D and vitamin D metabolites at 2 hours)
  • klotho(Change in level of circulation kloth at 2 hours)

研究者

发起方
Dr. Rachel Holden
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Rachel Holden

Principal Investigator

Queen's University

研究点 (1)

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