NCT01892202No Longer Available不适用
Efficacy of C.E.R.A for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 to 65 years of age inclusive
- •Patients with chronic kidney disease Stage III-IV not on dialysis
- •Hb < 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
- •Adequate iron status as judged by the treating physician
排除标准
- •Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •Significant acute or chronic bleeding
- •Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •Active malignant disease during the last five years (except non-melanoma skin cancer)
- •Uncontrolled or symptomatic secondary hyperparathyroidism
- •Epileptic seizure during the last 6 months
- •Poorly controlled hypertension (sitting blood pressure > 170/100 mmHG)
- •Myocardial infarction or stroke, or severe or unstable CAD
- •Severe liver disease during the previous 6 months
- •Congestive heart failure NYHA Class III-IV
- •Diagnosis or suspicion of pure red cell aplasia (PRCA)
- •Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
- •Transfusion of red blood cells during the previous 2 months
- •Pregnant women
- •Any contra-indications to Mircera
研究者
相似试验
已完成
不适用
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal AnemiaAnemiaNCT01677767Hoffmann-La Roche127
已完成
不适用
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)Kidney Disease, ChronicNCT02547454Hoffmann-La Roche393
已完成
不适用
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or DialysisAnemia, Kidney Disease, ChronicNCT01309295Hoffmann-La Roche250
已完成
2 期
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.AnemiaNCT00327535Hoffmann-La Roche153
已完成
1 期
A Study of Mircera in Anemic Patients With Multiple MyelomaAnemiaNCT00360347Hoffmann-La Roche