A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,415
- 试验地点
- 1
- 主要终点
- Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population
研究概览
简要总结
The primary purpose of this study is to describe renal anemia treatment patterns in non-dialysis dependent (ND) and dialysis dependent (DD) populations, with a particular focus on iron use in erythropoiesis stimulating agent (ESA) treated patients.
This study will also provide an epidemiological description of chronic kidney disease (CKD) associated anemia in relation to CKD stage, dialysis modality and underlying morbidity, as well as describe the relationship between inflammation and ESA treatment and describe the associated cardiovascular illness in ESA treated patients.
详细描述
Data from year 2015 will be used for the prevalence analysis.The prevalent population of CKD patients > 18 years in the Swedish Renal Registry in 2015 both dependent on dialysis (DD) and not on dialysis (ND).
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
- •For ND-CKD population:
- •all prevalent patients with a CKD with Estimated Glomerular filtration rate (eGFR) < 45ml/min/1.73m2 with a recorded visit pre-dialysis in Swedish Renal Registry (SRR) in 2015
- •Not on dialysis
- •For DD-CKD population
- •All prevalent patients taking part in the yearly cross-sectional dialysis investigation in SRR in 2015
- •Dialysis dependent
排除标准
- •not applicable
结局指标
主要结局
Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population
时间窗: 1 year (data from 2015)
Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population
时间窗: 1 year (data from 2015)
Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
次要结局
- ESA use in ND patients at each CKD stage(1 year (data from 2015))
- Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)(1 year (data from 2015))
- Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA(1 year (data from 2015))
- Proportion of ESA treated DD patients within Haemoglobin (Hb) levels within pre-specified target range(1 year (data from 2015))
- Proportion of DD patients with anemia who are not treated with ESAs(1 year (data from 2015))
- Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive medication(1 year (data from 2015))
- Number of ND patients with serious cardiovascular events(4 years (CV events may be compared from data covering 2012 to 2016))
- All cause mortality: ND(1 year (data from 2015))
- All cause mortality: DD(1 year (data from 2015))
- ESA use in DD patients(1 year (data from 2015))
- Proportion of DD patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron(1 year (data from 2015))
- Number of DD patients with serious thromboembolic events(1 year (data from 2015))
- Proportion of ESA treated ND patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations(1 year (data from 2015))
- Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations(1 year (data from 2015))
- Number of DD patients with serious cardiovascular events(4 years (CV events may be compared from data covering 2012 to 2016))
- Proportion of ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range(1 year (data from 2015))
- Proportion of ESA treated ND patients with low or medium and high C-reactive protein (CRP)(1 year (data from 2015))
- Proportion of ESA treated DD patients with low or medium and high CRP(1 year (data from 2015))
- Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive medication(1 year (data from 2015))
- Correlation between ESA dose and Hb level in relation to CKD severity (stage 3,4, 5 and DD)(1 year (data from 2015))
- Correlation between Haemoglobin (Hb) level and CKD severity: ND(1 year (data from 2015))
- Proportion of ND patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron(1 year (data from 2015))
- Proportion of ND patients with anemia who are not treated with ESAs(1 year (data from 2015))
- Correlation between ESA dose and CRP level: DD(1 year (data from 2015))
- Relationship between Hb level and occurrence of CV events in ND population(1 year (data from 2015))
- Relationship between Hb level and occurrence of CV events in DD population(1 year (data from 2015))
- Number of ND patients with serious thromboembolic events(1 year (data from 2015))
- Correlation between ESA dose and C-reactive protein (CRP) level: ND(1 year (data from 2015))
- Relationship between ESA dose and occurrence of Cardiovascular (CV) events in ND population(1 year (data from 2015))