A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (Also Known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients With Secondary Hyperparathyroidism
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent.
- •Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
排除标准
- •Subject pregnant or nursing
研究组 & 干预措施
Etelcalcetide
Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.
次要结局
- Percent Change From Baseline in Serum Phosphorus(Baseline and Weeks 13, 26 and 52)
- Percent Change From Baseline in Parathyroid Hormone(Baseline (of the parent study 20120331) and Weeks 13, 26 and 52)
- Percent Change From Baseline in Serum Corrected Calcium(Baseline and Weeks 13, 26 and 52)