跳至主要内容
临床试验/NCT02708368
NCT02708368已完成不适用

Investigation to Develop Standard Operating Procedures (SOP) for the Determination of Innovative CKD-MBD(Chronic Kidney Disease - Mineral Bone Disorder)-Serum-(Plasma-)Parameters

RWTH Aachen University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
an optimal analysis of innovative CKD-MBD-Biomarkers

研究概览

简要总结

CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Clinical pictures of peripheral artery occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. For this reason it makes sense to monitor these patients regularly. For this purpose the determination of different biomarkers would be appropriate for control of the course of disease.

During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP were established as indicators for the disease activity, as diagnostic criteria for the existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death) within the scope of CKD-MBD. For the clinical routine care application of these parameters standard operating procedures (SOP) are missing for the determination method relating to optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patients who are regularly (3 times a week) on dialysis in the Maria-Hilf-Clinic or healthy subjects
  • Male or Female at the age of at least 18 years
  • Patients who will be admitted to the clinics of the University Hospital RWTH Aachen or of the Maria-Hilf-Clinic Mönchengladbach or healthy subjects
  • written informed consent form
  • Subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel

排除标准

  • age < 18 years
  • subjects who are unwilling or not able to consent
  • pregnant or lactating women
  • subject has been committed to an institution by legal or regulatory order
  • dependency or working relationship with the investigator
  • participation in a parallel interventional clinical study
  • Hb-value < 10 g/dl

结局指标

主要结局

an optimal analysis of innovative CKD-MBD-Biomarkers

时间窗: through study completion, an average of 3 months

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 (2)

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