NCT01932970已完成3 期
A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
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
- 158
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
研究概览
简要总结
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Etelcalcetide
Experimental
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
时间窗: 4 weeks
次要结局
- Percent Change From Baseline in Parathyroid Hormone During the Treatment Period(Baseline and weeks 2, 3 and 4)
- Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period(4 weeks)
研究者
研究点 (1)
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