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临床试验/NCT01379963
NCT01379963已完成不适用

Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)

Hoffmann-La Roche17 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2009年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
780
试验地点
17
主要终点
Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)

研究概览

简要总结

This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, >/= 18 years of age
  • Renal anemia treated with Mircera for at least 6 months before entering study

排除标准

  • Patients who refuse or are incapable of giving their written informed consent to retrospective data collection

结局指标

主要结局

Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)

时间窗: Up to 6 months

Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.

次要结局

  • Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL(Up to 6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (17)

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