InspeCKD - Secondary Data Analysis of Patients at Risk for Chronic Kidney Disease (CKD) in German Primary Care Offices to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 800,211
- 试验地点
- 1
- 主要终点
- Percentage of patients with diagnosed CKD
研究概览
简要总结
This study is a national secondary data analysis to determine the prevalence of diagnosed and undiagnosed CKD in German primary care offices in a patient population at high risk for the development and progression of CKD. Furthermore, it addresses the question of how CKD screening, monitoring and treatment of these patients is conducted within the German primary care setting.
详细描述
The study does not attempt to test any specific a priori hypothesis; it is descriptive only. Data on general patient characteristics, health insurance details, participation in disease management programs and/or family doctor-centred care, diagnoses, prescriptions, surgeries, and procedures, used billable services and laboratory test results are documented during daily routine by the physician. The data used in this setting are part of routine visits, dating back a maximum of 24 months from the date of first data transfer within the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Age ≥ 18 years at start of the patient´s observation period
- •Having at least one of the following diseases (based on the documented ICD-10 code):
- •Type 1 diabetes
- •Type 2 diabetes
- •Hypertension
- •Cardiovascular disease, including:
- •Coronary and/or other atherosclerosis
- •Myocardial infarction
- •Heart failure
- •Peripheral arterial disease
- •Having at least one year (52 weeks) of observation period
排除标准
- 未提供
结局指标
主要结局
Percentage of patients with diagnosed CKD
时间窗: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
Percentage of patients with undiagnosed CKD
时间窗: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
Percentage of patients with undiagnosed or diagnosed CKD
时间窗: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes)
时间窗: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
次要结局
- Percentage of patients who did not have serum creatinine and UACR determined at least once(Dating back a maximum of 24 months from the date of first data transfer)
- BMI at index date(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Average number of serum creatinine measurements per patient per year (52 weeks) in the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Average number of UACR measurements per patient per year (52 weeks) during the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients in whom both serum creatinine and UACR were determined at least once(Dating back a maximum of 24 months from the date of first data transfer)
- Age at index date(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients in whom both serum creatinine and UACR were determined at least twice(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients with at least two serum creatinine measurements with an interval of at least three months among all eligible patients in the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients with at least two UACR measurements with an interval of at least three months among all eligible patients in the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients with at least two UACR and serum creatinine measurements with an interval of at least three months among all eligible patients in the study period(Dating back a maximum of 24 months from the date of first data transfer)
- Sex at index date(Dating back a maximum of 24 months from the date of first data transfer)
- Concurrent medication at index date(Dating back a maximum of 24 months from the date of first data transfer)
- Comorbidities at index date(Dating back a maximum of 24 months from the date of first data transfer)
- eGFR values at index date(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients among diagnosed or undiagnosed CKD patients that are newly initiated with either/or renin-angiotensin-system-inhibitors (ACEi, ARB), SGLT2i, statin, selective mineralocorticoid receptor antagonist within 6 months after index date(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients with impaired kidney function(Dating back a maximum of 24 months from the date of first data transfer)
- UACR values at index date(Dating back a maximum of 24 months from the date of first data transfer)
- Percentage of patients among diagnosed or undiagnosed CKD patients that are treated with either/or renin-angiotensin-system-inhibitors (ACEi, ARB), SGLT2i, statin or selective mineralocorticoid receptor antagonist at index date(Dating back a maximum of 24 months from the date of first data transfer)