Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,580
- 试验地点
- 1
- 主要终点
- Prevalence of AU and its severity.
研究概览
简要总结
Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease
详细描述
This register was sponsored and organized by the Association "Eurasian Association of Internal Medicine". It is a multicenter non-interventional register of real clinical practice. The database will include patients aged 40 years and older without pre-existing nephrological disease who are available for a dipstick test for albuminuria. The subjects will be identified by screening all patients who meet inclusion/exclusion criteria during routine outpatient and hospital follow-up. The register does not include follow-up (cross-sectional design).
Patients eligible for the register should be enrolled and documented. The procedure for obtaining informed consent for the collection and analysis of the retrospective data must comply with the local legislation. If necessary, patients will be asked to sign an informed consent document.
All study sites will use standardized electronic CRFs. The Electronic Data Capture (EDC) system should be validated in accordance with current standards and legal requirements. The investigators will log into this system using individual usernames and passwords. Data may only be entered and corrected by the investigator or other authorized study site personnel.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 40 and older at the time of data entry;
- •A possibility to check for albuminuria using dipsticks and/or analysis for microalbuminuria or albumin-to-creatinine ratio in a single urine sample.
排除标准
- •Unwillingness of the patient to participate in the register;
- •Diagnosis of CKD made before the screening for the register;
- •Diagnosis of diabetes mellitus (DM) type 1 or type 2 made before the screening for the register;
- •Pregnancy;
- •Long distance running or very strenuous physical activity in the last 24 hours.
结局指标
主要结局
Prevalence of AU and its severity.
时间窗: Day 1
Determination of AU by qualitative and/or quantitative methods
次要结局
- Frequency of prescribing renoprotective drugs.(Day 1)
- Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.(Day 1)
- Number of comorbidities per patient with AU.(Day 1)
- Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.(Day 1)