A Non-interventional Evaluation of the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45,637
- 试验地点
- 1
- 主要终点
- Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care
研究概览
简要总结
The objectives of this analysis is to determine the incidence of anemia occurring in patients with chronic kidney disease (CKD) in primary care (i.e. prior to any eventual referral to nephrology care). This analysis also evaluates patient characteristics, anemia treatment and associated cardiovascular risk.
详细描述
Data will be derived from the Stockholm CREATinine Measurement (SCREAM) cohort, a repository of laboratory data of individuals residing and accessing healthcare in the region of Stockholm and who underwent a creatinine assessment between 2012 - 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient entered in SCREAM between 2012 and 2018
- •With two consecutive plasma-creatinine test(s) indicating an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2
- •With at least one eligible Hb after eGFR < 60 mL/min/1.73 m^
- •The date of the first eligible Hb test is the study entry point/index date of the study.
排除标准
- •Patient who has had a recent pregnancy or childbirth (issued diagnosis within 2 years prior to index date).
- •Patient with ongoing/recent cancer (diagnosed within the previous 3 years), haematological diseases or leukaemia.
- •Patient with chronic infections (hepatitis, tuberculosis, or human immunodeficiency virus [HIV]); note by definition chronic infections are chronic and look back period will be to
- •Patients with anemia at baseline (index date), defined by an anemia diagnosis in the year prior, a baseline Hb value within the anemia range according to the WHO definition, or the presence of a recent dispensation of ESA or iron (up to six months prior).
- •Patient referred to nephrologist within the previous 2 years from cohort entry/ index date.
结局指标
主要结局
Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care
时间窗: 6 years at maximum
Anemia will be defined as the composite of: a diagnosis of anemia, a haemoglobin (Hb) measurement within the defined range for anemia followed by iron (oral or intravenous \[IV\]) or erythropoietin-simulating agent (ESA) treatment within 3 months, a Hb measurement within the defined range for anemia followed by another low Hb measurement \>3 months apart. Anemia as an outcome will be defined by current World Health Organization (WHO) definitions (Hb \< 12 g/dL or 7.45 mmol/L for female and \< 13 g/dL or 8.07 mmol/L for male). The incidence rate of anemia will be calculated as the number of new cases divided by person-time of CKD stage 3-5 patients who were "at risk" of becoming an incident anemia case.
次要结局
- Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients(On Day 1)
- Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients(On Day 1)
- Proportion of patients who initiated anemia treatment after incident of anemia(6 months)
- Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia exposed period(7 years at maximum)
- Correlation of incident anemia and the risk of MACE+ in patients in non-anemia exposed period(7 years at maximum)
- Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia non-exposed period(7 years at maximum)
- Correlation of incident anemia and the risk of MACE+ in patients in anemia exposed period(7 years at maximum)
- Correlation of incident anemia and the risk of death in patients with anemia(7 years at maximum)