NCT01788046已完成3 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
研究概览
简要总结
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •Subject is 18 years of age or older.
- •Subject agrees to not participate in another study of an investigational agent during the study.
- •Subject must be receiving hemodialysis 3 times weekly for at least 3 months
- •Other Inclusion Criteria may apply
排除标准
- •Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
- •Other investigational procedures while participating in this study are excluded.
- •Anticipated or scheduled parathyroidectomy during the study period.
- •Subject has received a parathyroidectomy within 3 months prior to dosing.
- •Anticipated or scheduled kidney transplant during the study period.
- •Subject has known sensitivity to any of the products or components to be administered during dosing.
- •Subject has participated in a prior clinical trial of AMG 416
- •Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
- •Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
- •Other Exclusion Criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
干预措施: Placebo (Drug)
Etelcalcetide
Experimental
Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
时间窗: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
次要结局
- Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase(Baseline and the efficacy assessment phase (Week 20 to Week 27))
- Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase(Baseline and the Efficacy Assessment Phase (Week 20 to Week 27))
- Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase(Baseline and the efficacy assessment phase (Week 20 to Week 27))
- Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase(Baseline and the efficacy assessment phase (Week 20 to Week 27))
- Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase(Baseline and the efficacy assessment phase (Week 20 to Week 27))
研究者
研究点 (1)
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