Incidence and Clinical Burden of Erythropoietin Hyporesponsiveness - a Retrospective Database Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85,259
- 试验地点
- 1
- 主要终点
- Phase 1 Part: Rate of ESA hyporesponsive events
研究概览
简要总结
This study consists of two phases. The purpose of phase 1 is to identify incidence and patterns of erythropoiesis-stimulating agent (ESA) hyporesponsiveness and its associated factors in ESA treated patients. The purpose of phase 2 to identify outcomes associated with ESA hyporesponsiveness. Key aspects of the phase 2 study design will entirely depend on the results from phase 1.
详细描述
This is a retrospective database analysis of patients with anemia associated with chronic kidney disease (CKD) treated with ESAs from January 1st 2015 - December 31st 2021. Data will be derived from European Clinical Database (EuCliD).
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
- •All patients
- •Patient has a diagnosis of chronic kidney disease valid between January 1st, 2015, and December 31st, 2021 and is documented in the EuCliD database (incident and prevalent patients)
- •Patient who is treated with renal replacement therapy (RRT) (CKD Stage 5) during the study period
- •Patient receiving erythropoiesis-stimulating agent (ESA) therapy, within the data collection period having EuCliD data available for a period of the previous 30 days before Index Date but not strictly limited to patients that enter the study period as ESA naïve patients
- •Patient having provided consent for secondary use of their data for research purposes
- •Patient has a known ESA administration route (intravenous/subcutaneous)
- •Patient with a hemoglobin value available at baseline (+/- 20 days allowed) and at least one valid hemoglobin value afterwards
- •Patient having at least one body weight value available
- •Hyporesponsive Cohort
- •Patients meeting the hyporesponsive criteria on at least one occasion. The criteria for ESA hyporesponsive will follow the National Institute for Health and Care Excellence, UK (NICE) guidelines:
- •for epoetin alfa, 300 IU/kg/week or more of subcutaneous epoetin or 450 IU/kg/week or more of intravenous epoetin
- •for darbepoetin, dose ≥ 1.5 μg/kg per week
- •Responsive Cohort
- •Patients with all ESA doses lower than those defined by the hyporesponsive criteria
排除标准
- •Patient with evidence of hereditary hemolytic anemia (International Classification of Diseases 10th Revision [ICD-10] code D58.9)
- •Patient receiving transplant within 6 months prior to Index Date
结局指标
主要结局
Phase 1 Part: Rate of ESA hyporesponsive events
时间窗: Up to 12 months
The total number of patients with a new hyporesponsive event in relation to National Institute for Health and Care Excellence, UK (NICE) guidelines within a year after the ESA dose start will be counted as incidence. For deriving the incidence rate, the number of incidence cases will be divided by the sum of the time (days) each patient was observed within this group, totaled for all patients in this ESA subgroup.
次要结局
- Phase 1 Part: Correlation of hyporesponsiveness and patient characteristics over time(Up to 12 months)
- Phase 1 Part: Time from the start of ESA dose to the first hyporesponsive event(Up to 12 months)
- Phase 1 Part: Characteristics on date of first incidence satisfying hyporesponsiveness criteria(Up to 12 months)
- Phase 1 Part: Percentage of ESA hyporesponsiveness in relation to the KDIGO definition(At 12 months)
- Phase 1 Part: Distribution of ESA hyporesponsiveness patients(Up to 12 months)
- Phase 1 Part: Baseline characteristics(Day 1 (start of ESA treatment))
- Phase 1 Part: Percentage of ESA hyporesponsiveness per Clinical Practicability Algorithm(At 12 months)