EUCTR2007-001721-97-AT进行中（未招募）不适用
An single arm, open label, interventional multicenter study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. for themaintenance of haemoglobin levels in hemodialysis patients with chronic renal anaemia - MIRACLE
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
- •1. Written informed consent
- •2. Age 18 years or older
- •3. Chronic renal anaemia
- •4. Haemoglobin concentration in the country specific target range (Switzerland: between 11 g/dL and 13 g/dL; Austria: between 10 g/dL and 12 g/dL)
- •5. Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
- •6. Continuous intravenous or subcutaneous maintenance darbepoetin alfa, epoetin alfa or epoetin beta therapy with the same dosing interval (1-3 x weekly or 1 x 2-weekly) during the previous 2 months
- •7. Regular long-term haemodialysis therapy with the same mode of dialysis for at least the previous 3 months
- •8. Kt/V = 1.2 measured either by blood sampling or online monitoring at screening for haemodialysis patients (or URR =65%) and a minimum of three dialysis sessions per week
- •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
- •1. Transfusion of red blood cells during the previous 2 months
- •2. Poorly controlled hypertension at investigator’s discretion
- •3. Significant acute or chronic bleeding such as overt gastrointestinal bleeding
- •4. Active malignant disease (except non-melanoma skin cancer)
- •5. Haemolysis: haptoglobin <30 mg/dL (3.54 mmol/L) or other reliable positive test of haemolysis
- •6. Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •7. Folic acid deficiency
- •8. Vitamin B12 deficiency
- •9. Platelet count >500 x 109/L or <100 x 109/L
- •10. Pure red cell aplasia
- •11. Epileptic seizure during previous 6 months
- •12. Active infection or inflammation at investigator's discretion
- •13. Congestive heart failure (NYHA Class IV)
- •14. Myocardial infarction or stroke. Severe or unstable coronary artery disease, severe liver disease at investigator’s discretion during the previous 3 months
- •15. Uncontrolled or symptomatic secondary hyperparathyroidism at investigator’s discretion
- •16. Pregnancy or lactation period
- •17. Women of childbearing potential without effective contraception
- •18. Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months
- •19. Life expectancy <12 months
- •20. Planned (date) elective surgery during the study period except for
- •21. cataract surgery
- •22. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •23. Temporary (untunneled) dialysis access catheter
研究者
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