ACTRN12608000199314已完成4 期
A randomised, placebo-controlled trial of oxpentifylline on erythropoietin resistance in patients with erythropoietin-resistant anaemia
Australasian Kidney Trials Network0 个研究点目标入组 53 人开始时间: 2008年4月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
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. Stage 4 or 5 chronic kidney disease 2. Haemoblobin concentration less than or equal to120 g/L 3. ERI greater than or equal to1.0 IU/kg/week/gHb for Erythopoietin (EPO) treated patients and greater than or equal to 0.005 micrograms/kg/week/g Hb for darbepoetin (DPO) treated patients. 4. Stable EPO or DPO dosage for at least 8 weeks. 5. 18 years or over. 6. 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, oxpentifylline or other methylxanthines such as caffeine, theophylline or theobromine 4. History of major gastrointestinal bleeding or any gastrointestinal bleeding in the past 12 weeks. 5. Absolute or functional iron deficiency (ferritin less than 100 microg/L and/or transferrin saturation less than 20%)
- •6. Vitamin B12 or folate deficiency 7. Parathyroid hormone level greater than 100 pmol/L 8. Serum aluminium greater than 2 micromol/L 9. Urea reduction ratio less than 65% or single pool Kt/V less than 1.0 (haemodialysis patients) or total weekly Kt/V less than 1.7 (peritoneal dialysis patients) 10. Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy 11.Active haemolysis 12. Any surgery within the last 6 weeks
- •13. Infection within 6 weeks of the last dose of antibiotic, acute myocardial infarction or malignancy within the last 6 weeks 14. Melatonin treatment, androgen therapy or blood transfusion within the previous 4 weeks 15. Vitamin C therapy at dose greater than 1000mg/day or at a dose which has changed within the last 12 weeks
- •16. Haemorrhagic stroke or severe haemorrhage within the last 12 weeks 17. Current immunosuppressant use, or immunosupression during previous 4 weeks
研究者
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