NCT02042833已完成不适用
An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 815
- 主要终点
- Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6
研究概览
简要总结
This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 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
- •Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation)
- •Treated or not with ESA at time of visit
- •Patients for whom the treating physician had decided to initiate Mircera for medical reasons before the commencement of the study
- •Initiation of treatment with Mircera at the inclusion visit
- •Accepting and able of completing the ESA preference questionnaire
排除标准
- •Participation in a clinical trial on anemia
- •Treatment with Mircera during the 3 months before inclusion
- •Dialysis planned in the next 6 months
结局指标
主要结局
Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6
时间窗: 6 months
次要结局
- Concomitant medication/treatments in the management of anemia(6 months)
- Change in hemoglobin level(from baseline to Month 6)
- Safety: Incidence of adverse events(6 months)
- Biological parameters: hemoglobin concentration at each observation time point.(6 months)
- Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6(6 months)
- Dose/schedule of Mircera treatment at each observation timepoint(6 months)
- Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera(Month 6)
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