EUCTR2008-003173-40-IT进行中（未招募）不适用
A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of subcutaneous C.E.R.A. for the maintenance of haemoglobin levels in pre-dialysis patients with chronic renal anaemia - ORIO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
- •Continuous subcutaneous maintenance darbopoetin alfa therapy with the same dosing interval during the previous month and no change in total (calculated) weekly dose.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Transfusion of red blood cells during the previous 2 months
- •Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months
- •Significant acute or chronic bleeding such as overt gastrointestinal bleeding
- •Active malignant disease (except non-melanoma skin cancer)
- •Haemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types)
- •Folic acid deficiency
- •Vitamin B12 deficiency
- •Platelet count >500 x 109/L or <100 x 109/L
- •Pure red cell aplasia
- •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
- •Uncontrolled or symptomatic secondary hyperparathyroidism
- •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 3 months
- •Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •Planned (date) elective surgery during the study period except for
- •cataract surgery
- •vascular access surgery
研究者
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