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临床试验/ACTRN12609000432213
ACTRN12609000432213招募中3 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)

Professor David Johnson0 个研究点目标入组 60 人开始时间: 2009年6月10日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
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
Open (masking not 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 for 1 month or longer.
  • 2.On DPO for 1 month or longer.
  • 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 > 100 pmol/L.
  • 8.Serum aluminium > 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 500 microgram/mL or greater or transferrin saturation (TSAT) 50% or greater.
  • 13.Religious or other objection to consuming product prepared from bovine blood.

研究者

发起方
Professor David Johnson

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