ACTRN12610000678099已完成4 期
A randomised controlled trial of oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.On peritoneal dialysis greater than or equal to 1 month.
- •2.On darbepoetin for greater than or equal to 1 month
- •3.18 years or over.
- •4.Able to give informed consent.
排除标准
- •1.Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study.
- •2.Pregnancy or breast-feeding.
- •3.Known hypersensitivity to, or intolerance of, oral iron, HIP or DPO.
- •4.Active peptic ulcer disease.
- •5.Vitamin B12 or folate deficiency.
- •6.Recent (within 1 month) acute infection.
- •7.Parathyroid hormone level greater than 100 pmol/L.
- •8.Serum aluminium greater than 2 micromol/L.
- •9.Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy
- •10.Major surgery, infection, acute myocardial infarction or malignancy within the last 3 months.
- •11.Intravenous iron therapy, vitamin C therapy, melatonin treatment, androgen therapy or blood transfusion within the previous month.
- •12.Serum ferritin greater than 500 microg/mL or transferrin saturation (TSAT) greater than 50%.
- •13.Religious or other objection to consuming product prepared from bovine blood.
研究者
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