FGF-23 and PTH During Hemodialysis Patients Under Consideration of Calcification Propensity - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time course of FGF-23 and PTH levels during hemodialysis treatment.
研究概览
简要总结
In this pilot study the investigator will examine the levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH) levels during hemodialysis therapy in 30 patients and assess the correlation between these parameters and the T-50 calcification propensity, as well as further parameters of secondary hyperparathyroidism (sHPT), like serum calcium (sCa), phosphate (P), 25-hydroxy-vitamin D (25(OH)D) and 1,25 dihydroxy-vitamin D (1,25(OH)2D).
The investigator hypothesize that FGF-23 and PTH levels are at their highest at the beginning of dialysis and decrease during the treatment.
详细描述
Background: The development of sHPT in hemodialysis patients is a common complication which induces an increase in calcification and atherosclerosis. Elevated FGF-23 levels are already found in early stages of chronic kidney disease (CKD) and it has been shown that high FGF-23 levels are associated with the development of cardiovascular disease and increased overall mortality.
Method: In this pilot study a total number of 30 patients on maintenance haemodialysis will be enrolled. The investigator will examine the course of FGF-23 and PTH levels during a single hemodialysis session. In addition, the T-50 time, a novel non-traditional cardiovascular risk factor as well as further parameters of sHPT, such as serum calcium (sCa), phosphate (P), 25-hydroxy-vitamin D (25(OH)D) and 1,25 dihydroxy-vitamin D (1,25(OH)2D) will be assessed.
Hypothesis and specific aims: The major end point of the study is the level of FGF-23 and PTH at three points during hemodialysis treatment. As secondary end points the T-50 calcification propensity and further parameters of sHPT, as well as the correlation between these parameters will be measured.
Hemodialysis is classified as a kidney replacement therapy and FGF-23 and PTH are partly metabolized and excreted by the kidneys. Based on this the investigator hypothesize that FGF-23 and PTH levels are at their highest at the beginning of dialysis and decrease during the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •hemodialysis three times a week
排除标准
- •Subject is currently enrolled or not yet completed at least 30 days since ending other investigational device or drug trial(s), or is receiving other investigational agent(s)
- •Pregnancy
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
结局指标
主要结局
Time course of FGF-23 and PTH levels during hemodialysis treatment.
时间窗: 1 day
This trial is designed to analyze the levels of fibroblast growth factor 23 and parathyroid hormone concentrations during hemodialysis treatment. Measurements will be performed at three timepoints during one single treatment session on one single treatment day. The first measurement will be performed at the beginning of dialysis (just after connecting the patient to the dialysis machine), the second after two hours of dialysis and the third at the end of the dialysis treatment (before disconnecting the patient from the machine).
次要结局
- T-50 calcification, sHPT parameters(1 day)
研究者
Rainer Oberbauer
Univ.-Prof. Rainer Oberbauer, MD, PhD
Medical University of Vienna