跳至主要内容
临床试验/NCT01886950
NCT01886950招募中不适用

A Prospective Observational Study to Investigate the Natural History of Bone Histomorphometry and Vascular Calcification in Dialysis-dependent Patients Before and After Renal Transplantation.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2010年8月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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