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临床试验/NCT00298441
NCT00298441已完成4 期

Effect of IVIR Frequency on Anemia Correction and Oxidative Stress Formation and in Hemodialysis Patients

Kumamoto University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年6月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
2
主要终点
hemoglobin levels at 24 weeks

研究概览

简要总结

The purpose of this study is to determine whether the frequency of intravenous iron administration has an effect on anemia correction and oxidative stress formation in hemodialysis patients.

详细描述

In patients who are on chronic hemodialysis (HD), anemia is a major complication and is associated with poor clinical outcomes. Consequently, management of anemia by recombinant erythropoietin is reported consistently to improve outcome measures in HD patients. Because iron is essential for hemoglobin formation, as is erythropoietin, most patients routinely receive iron intravenously (IVIR) for anemia correction. Although IVIR has been shown to improve both survival and quality of life of HD patients, it has been suggested that IVIR may enhance the generation of hydroxyl radicals in the body through the inflammation process and the Fenton reaction. Previously we demonstrated that that serum albumin is highly oxidized in HD patients and that IVIR on these patients significantly increased the oxidation status of albumin.

In 2004, the committee on the guidelines of the Japanese Society for Dialysis Therapy (JSDT) published the original Japanese "Guidelines for Renal Anemia in Chronic Hemodialysis Patients". In the JSDT guidelines 2004, the committee recommended two IVIR schedules for iron deficient patients; 1) administer 40 mg of IV iron at the end of dialysis session 3 times a week for 4 weeks (total 520 mg of iron), 2) administer 40 mg of IV iron at the end of dialysis session once a week for 3 months (total 520 mg of iron). Both administration schedules are effective for the correction of iron deficiency and consequently for the amelioration of anemia. However, the effect of IVIR frequency (three times a week vs. once a week) on the oxidative stress formation has not been investigated before.

Comparison: the two IVIR schedules recommended by the JSDT guideline 2004 will be compared by measuring both hemoglobin and oxidized albumin in chronic HD patients.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of chronic renal failure
  • •Clinical diagnosis of iron deficiency anemia
  • •Must be on regular hemodialysis

排除标准

  • •Allergic to intravenous iron administration

结局指标

主要结局

hemoglobin levels at 24 weeks

oxidized albumin levels at 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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