NCT00146224已完成3 期
A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 420
- 主要终点
- Ratio of weekly dose at the evaluation period to the weekly dose at baseline
研究概览
简要总结
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization
排除标准
- •Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
研究组 & 干预措施
Epoetin alfa RB
Active Comparator
干预措施: Epoetin alfa RB (Drug)
Epoetin alfa DT
Experimental
干预措施: Epoetin alfa DT (Drug)
结局指标
主要结局
Ratio of weekly dose at the evaluation period to the weekly dose at baseline
时间窗: Entire Study
Change in Heloglobin level between the screening period and the evaluation period
时间窗: Entire Study
次要结局
- Change from baseline Hb at each measurement timepoint(Entire Study)
- Maintaining Hemoglobin within range at each measurement timepoint(Entire Study)
- Average Epoetin alfa dose over evaluation period(evaluation period (weeks 21 - 28))
- Change from baseline dose at each measurement timepoint(entire study)
- Epoetin alfa seroreactivity(entire study)
- Subject incidence, nature and severity of adverse events(entire study)
- Hemoglobin variability(entire study)
- changes from baseline laboraotry and vital sign parameters(entire study)
研究者
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