NCT02691546已完成不适用
Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
Istituto Nazionale di Ricovero e Cura per Anziani8 个研究点 分布在 7 个国家目标入组 2,434 人开始时间: 2016年8月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,434
- 试验地点
- 8
- 主要终点
- Incidence of End Stage Renal Disease (ESRD)
研究概览
简要总结
The SCOPE study is an observational, multicenter, prospective cohort study aimed at evaluating a 2-year screening programme for CKD in a population of older patients, aged 75 years or more, in seven European Countries, in an attempt to investigate whether and to which extent currently available screening methods may identify older people at risk of worsening kidney function.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age≥75 years
- •subjects attending the outpatient services at participating institutions
排除标准
- •ESRD or dialysis
- •history of solid organ or bone marrow transplantation
- •active malignancy within 24 months prior to screening or metastatic cancer
- •life expectancy less than 6 months
- •severe cognitive impairment (MMSE<10),
- •any medical or other reason that the subject is unsuitable for the study
- •subjects unwilling to provide consent
结局指标
主要结局
Incidence of End Stage Renal Disease (ESRD)
时间窗: 24 months
ESRD will be defined as eGFR\<15 mL/min/1.73 m2 or dialysis
Rate of estimated Glomerular Filtration Rate (eGFR) decline
时间窗: 24 months
eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation
次要结局
- Biomarkers of kidney function(Baseline and 24 months)
- Genetic and epigenetic analyses(Baseline and 24 months)
- Incidence of major comorbidities(24 months)
- Incidence of CKD complications(24 months)
- Comprehensive geriatric assessment (CGA)(Baseline and 24 months)
- Healthcare resource consumption(Baseline and 24 months)
- Cardiovascular mortality(24 months)
研究者
研究点 (8)
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