Prospective Evaluation of Serum Klotho, a Novel Biomarker, as a Predictor of Progression of Cardiovascular Calcification (CVC) in Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- The relationship between CVC and serum Klotho
研究概览
简要总结
This prospective observational study aims to investigate the relationship between CVC and serum Klotho for renal function correction in patients with different CKD stages
详细描述
In this study, we plan to enroll 400 non-dialysis patients with CKD 2-5 and 300 maintenance hemodialysis patients. Participants will receive coronary artery computed tomography (CT) scanning to detect the extent and the severity of CVC. Follow-up is scheduled at 0, 6, 12, 18, and 24 months and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), total calcium, phosphate, parathyroid hormone (PTH), serum 25(OH) vitamin D, fibroblast growth factor-23 (FGF-23) and coronary artery computed tomography (CT).
The purpose of this study was to clarify the relationship between CVC in patients with different CKD stages and serum Klotho for renal function correction, and to clarify that Klotho can be used as an early biomarker for CVC in patients with CKD, so as to predict the occurrence and progress of CVC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •age over 18 years old, regardless of gender
- •non-dialysis patients with CKD 2-5, or patients with CKD 5 under hemodialysis for more than 3 months
排除标准
- •life expectancy < 2 years
- •severe complications of heart, lung, liver or brain
- •primary hyperparathyroidism
- •malignant tumor
- •pregnant or breastfeeding
- •contraindications to CT examination
- •unwilling or unable to comply with the research protocol
结局指标
主要结局
The relationship between CVC and serum Klotho
时间窗: From date of enrollment until the end of study, assessed up to 24 months
To clarify the relationship between CVC and serum Klotho for renal function correction in patients with different CKD stages, and to clarify that Klotho can be used as an early biomarker for CVC in patients with CKD, so as to predict the occurrence and progress of CVC
次要结局
- The sensitivity and specificity of serum Klotho in the detection of CVC(From date of enrollment until the end of study, assessed up to 24 months)