CTRI/2009/091/000455已完成4 期
A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous or subcutaneous MIRCERA for the maintenance of haemoglobin levels in dialysis patients with chronic renal anaemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •? Written informed consent
- •? Age 18 years or older
- •? Chronic renal anaemia
- •? Haemoglobin concentration between 10.0 g/dl and 12.0 g/dL
- •? Adequate iron status as judged by Investigator
- •? Continuous intravenous or subcutaneous maintenance epoetin alfa therapy with the same dosing interval during the previous 2 months
- •? Regular long-term haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 2 months
排除标准
- •? Blood transfusion during the previous 1 month
- •? Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication requiring hospitalization or interruption of epoetin alfa treatment in the previous 2 months
- •? Significant acute or chronic bleeding such as overt gastrointestinal bleeding
- •? Medically significant dialysis inadequacy
- •? Known malignant disease (except non-melanoma skin cancer)
- •? Known history of Haemolysis
- •? History of Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •? Platelet count >500 x 109/L or <100 x 109/L
- •? History of Pure red cell aplasia
- •? Known Folic acid deficiency (uncorrected in past 2 months)
- •? Known Vitamin B12 deficiency (uncorrected in past 2 months)
- •? Epileptic seizure during previous 6 months
- •? Congestive heart failure (NYHA Class IV)
- •? Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months
- •? Pregnancy or lactation period
- •? Women of childbearing potential without effective contraception
- •? Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous
- •? Planned (date) elective surgery during the study period
研究者
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