EUCTR2006-006707-36-EE进行中（未招募）不适用
A single arm, open label study to assess the efficacy, safety, and tolerability of monthly administration of subcutaneous RO0503821 for the treatment of chronic renal anaemia in patients not on dialysis and not currently treated with ESA.
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 Oy
- 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
- •- Patients with chronic kidney disease stage 3 (GFR 30-59 ML/min) or stage 4 (GFR 15-29 ML/min) not requiring dialysis. The GFR can be estimated either by using the Cockroft-Gault formula or the MDRD formula
- •- Chronic renal anaemia
- •- Haemoglobin concentration between 9 and 11 g/dl at the initial screening visit
- •- No prior ESA therapy for 12 weeks prior to and throughout the screening period
- •- Adequate iron status (serum ferritin = 100ng/mL or TSAT=20%) during screening
- •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
- •- Change in haemoglobin concentration = 2g/dL during the 4 weeks screening period
- •- Transfusion of red blood cells during the 8 weeks prior to the screening visit or during the screening period
- •- Poorly controlled hypertension
- •- Relevant 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
- •- 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 at screening visit
- •- Pure red cell aplasia
- •- Epileptic seizure in 6 months before screening
- •- Congestive heart failure (NYHA Class IV)
- •- High likelihood of early withdrawal or interuption of the study (e.g. Myocardial infarction or stroke within 12 weeks of screening, severe or unstable coronary artery disease, severe liver disease)
- •- Failing renal allograft in place (renal graft rejection)
- •- Immunosuppressive therapy (other than corticosteroids for a chronic condition) in 12 weeks before screening
- •- Uncontrolled or symptomatic secondary hyperparathyroidism
- •- Pregnancy or lactation period
- •- Women of childbearing potential without effective contraception
- •- Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit
- •- Planned elective surgery during the study period except for
- •- cataract surgery
- •- vascular access surgery
- •- Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •- Previous treatment with RO0503821
研究者
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