A Prospective Observational Study to Investigate the Natural History of Bone Histomorphometry and Vascular Calcification in Dialysis-dependent Patients Before and After Renal Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Evolution of bone turnover, as assessed by bone biopsy
研究概览
简要总结
A study of the natural history of bone and mineral disease (BMD) in patients with end-stage renal disease before and after kidney transplantation
详细描述
Disturbances of mineral and bone diseaeses are frequently observed in CKD patients. Renal osteodystrophy is the term to describe the bone abnormalities. Epidemiological data showed adynamic bone disease (ABD) is the most frequent bone disorder in CKD stage 5D diseases. Low PTH, diabetes mellitus, malnutrition, metabolic acidosis, hypogonadism and low 1,25(OH)2D vitamin D deficiency are known risk factors for ABD. Mounting experimental data point towards a role of protein-bound uremic retention molecules (p-cresyl sulfate and indoxyl sulfate) in the pathogenesis and progression of ABD. ABD is not only recognized as a risk factor for fractures but also for arterial calcification.
The aim of the present study is (1) to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5 and (2) to investigate the influence of renal transplantation on bone and arterial metabolism.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible for renal transplantation and >18 years
排除标准
- •use of biphosphonates within the 6 months before the study entry
结局指标
主要结局
Evolution of bone turnover, as assessed by bone biopsy
时间窗: after 1 year
to evoluation the evolution of bone turnover after succesfull renal transplantation
aortic calcification, as assessed by lumbar X-ray
时间窗: 1 year
the assess the evolution of (the degree of) aortic calcification one year after succesfull renal transplantation
bone turnover, as assessed by bone biopsy
时间窗: at the start of the study
to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5
次要结局
未报告次要终点
