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临床试验/NCT02707757
NCT02707757已完成4 期

Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia

Imperial College Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Iron sucrose 200mg for 5 doses

干预措施: Iron sucrose (Drug)

Neorecormon

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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