NCT01213485已完成不适用
Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 主要终点
- Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice
研究概览
简要总结
This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 years of age
- •Chronic kidney disease, on dialysis for > 3 months
- •Treatment-naïve or previous treatment with ESA
- •Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician
排除标准
- •Participation in a clinical trial
- •Anemia due to an associated malignant pathology
结局指标
主要结局
Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice
时间窗: Month 6
Haemoglobin levels
时间窗: Month 6
次要结局
- Change in haemoglobin/haematocrit(from baseline to Month 12)
- Biological parameters of anemia: transferrin saturation, serum ferritin, folates(12 months)
- Efficacy of dialysis (Kt/V, urea levels)(12 months)
- Safety: Incidence of adverse events(12 months)
- Compliance (treatment modification or discontinuation)(12 months)
- Quality of life: Short Form (SF-36) questionnaire(12 months)
研究者
相似试验
已完成
不适用
Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney DiseaseChronic Kidney DiseaseAnemiaCardiomyopathyNCT00883415University of Maryland, Baltimore20
已完成
不适用
Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.Cardiovascular DiseasesChronic Kidney DiseaseNCT02987465Cambridge University Hospitals NHS Foundation Trust29
Unknown
不适用
Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart DiseaseChronic Kidney DiseaseCoronary Heart DiseaseNCT02509013Peking University First Hospital10,000
已完成
不适用
Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)Chronic Kidney DiseasesNCT02691546Istituto Nazionale di Ricovero e Cura per Anziani2,434
终止
不适用
Study of South African Dialysis PatientsChronic Kidney Disease, Receiving DialysisNCT01890577Amgen28