A Prospective Registry Study Observing the Safety and Patterns of Use of Darbepoetin Alfa in EU Paediatric Chronic Kidney Disease Patients Receiving or Not Receiving Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 321
- 主要终点
- Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
研究概览
简要总结
This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anaemia attributed to Chronic Kidney Disease (CKD)
- •Sixteen years of age or under
- •Documented CKD as demonstrated by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² (Schwartz equation) for ≥3 months if not on dialysis, or: Receiving dialysis
- •Treatment with darbepoetin alfa
- •Documented informed consent by a parent or authorised individual, if required, and assent by the patient if appropriate
排除标准
- •Active malignancy or current chemotherapy or radiation therapy
- •Investigator unlikely to be able to obtain adequate follow-up information, or participant will not be available for follow-up assessment
- •Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; subject receiving other investigational agents
结局指标
主要结局
Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)
时间窗: 2 years
An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).
次要结局
- Parathyroid Hormone Level by Three Monthly Intervals(Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24)
- Hemoglobin Concentration by Three Monthly Intervals(Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24)
- Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals(Baseline and Months 1 to 24)
- Number of Participants With Non-serious Adverse Drug Reactions (ADRs)(2 years)