Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
研究概览
简要总结
Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months
排除标准
- •Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.
研究组 & 干预措施
Iron sucrose
Iron sucrose 200mg for 5 doses
干预措施: Iron sucrose (Drug)
Neorecormon
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
干预措施: Erythopoietin stimulating agent (Drug)
结局指标
主要结局
Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
时间窗: 2 months
次要结局
未报告次要终点
