EUCTR2007-001720-13-NL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 RO0503821 for the maintenance of haemoglobine levels in patients with chronic renal anaemia not on dialysis (CKD stage 1-4) - ARIANE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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 10.5 and 12.5 g/dl (6.5 and 7.8
- •mmol/L) at the initial screening visit.
- •Adequate iron status (serum ferreting = 100ng/mL or TSAT=20%) during
- •Continuous subcutaneous maintenance darbepoetin alfa or epoetin beta
- •therapy with the same dosing interval for 8 weeks prior to and throughout
- •the screening period
- •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 8 weeks prior to or during the
- •screening period
- •Poorly controlled hypertension, i.e. sitting bloodpressure exceeds 170/100
- •despite medication requiring hospitalisation or interruption of epoetin beta
- •or darbepoetine alfa treatment in the previous 6 months.
- •Significant or acute or chronic bleeding, i.e. requiring therapy within 8
- •weeks prior to screening e.g. overt gastrointestinal bleeding
- •Active malignant disease (except non-melanoma skin cancer)
- •Haemolysis
- •Haemoglobinpathies (e.g. homozygous sickle-cell disease, thalassemia of
- •Folic acid deficiency
- •Vitamin B12 deficiency
- •Platelet count > 500 x 109/L or <100 x 109/L at screening visit
- •Pure red call aplasia
- •Epileptic seizure in 6 months before screening
- •Congestive heart failure (NYHA Class IV)
- •Myocardial infarction or stroke within 12 weeks of screening, severe or
- •unstable coronary artery disease, severe liver disease
- •Uncontrolled or symptomatic secondary hyperparathyroidism
- •Pregnancy or lactation period etc.
- •Women of childbearing potential without effective contraception
- •Participation in a clinical trial or receipt of investigational compound in the
- •3 months prior to the initial screening visit
- •Planned elective surgery during the study period except for cataract
- •surgery and vascular access surgery
- •Known hypersensitivity to recombinant human erythropoietin,
- •polyethylene glycol or to any constituent of the study medication
研究者
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