NCT01763242已完成4 期
EMAN-Anaemia: An Open Labelled Randomised Control Trial of the Synchronized Electronic MANagement of Anaemia in Chronic Kidney Disease (CKD) Compared to Usual Care Anaemia Management
Western Health, Australia2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Haemoglobin
研究概览
简要总结
Aims:
- To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).
- To compare this electronic process with "present anaemia management" in the traditional outpatient setting.
- To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.
详细描述
CKD Stages 3 to 5 Subjects will be randomised and stratified according to Age, Gender, CKD Stage, Known Cardiovascular Disease, Diabetes and ESA Type into EMAN vs. Control
Details of EMAN synchronization and Dosing:
Monthly dose of ESA is calculated by:
Monthly dose = present dose x (28/present frequency (days))
Synchronization will be achieved by using the formula: "Synchronization dose of ESA = (28-Days until next injection is due)/28 x monthly dose of ESA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent
- •Age > 18 years
- •Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria
排除标准
- •Pregnancy
- •Significant acute bleeding such as overt gastrointestinal bleeding
- •A known haematological cause for anaemia
- •Known metastatic malignancy
- •Present participation in another interventional clinical trial • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
结局指标
主要结局
Haemoglobin
时间窗: 12 months
Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.
次要结局
- Deaths(12 months)
- Quality of Life(12 months)
- Missed Doses of ESA(12 months)
- Fe Targets(12 months)
- Thrombosis Events(12 months)
- Renal Replacement Therapy Commencement(12 months)
- All Cause Hospitalisation(12 months)
- Outpatient Review Numbers(12 months)
- Primary Care review Numbers(12 months)
- Cardiovascular Hospitalisation(12 months)
- Cerebrovascular Hospitalisation(12 months)
- Peripheral Vascular Hospitalisation(12 months)
- Blood Transfusion Numbers(12 months)
- Fe Transfusion Numbers(12 months)
- Total Adverse Events(12 months)
- Anaemia Co-Ordinator Time(12 months)
- Pharmacy Time(12 months)
- Courier Costs(12 months)
- Ambulance Transfer Numbers(12 months)
- Cardiac and Vascular Biomarker Analysis(12 months)
研究者
Dr Craig Nelson
Head of Unit - Nephrology
Western Health, Australia
研究点 (2)
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