NCT01134562已完成1 期
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
KAI Pharmaceuticals0 个研究点目标入组 28 人开始时间: 2010年9月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 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 characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Subjects provides written informed consent.
- •Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and < 1200 pg/ml for Cohorts 1-3).
- •Serum corrected calcium ≥ 9.0 mg/dL
- •Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea * dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)
- •Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests
排除标准
- •History or symptomatic ventricular dysrhythmias
- •History of angina pectoris or congestive heart failure
- •History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
- •History of or treatment for seizure disorder
- •Recent (3 months) parathyroidectomy
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
干预措施: Placebo (Drug)
Etelcalcetide
Experimental
Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
次要结局
- Percent Change From Baseline in Serum Parathyroid Hormone (PTH)(Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29)
- Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide(Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).)
- Percent Change From Baseline in Serum Corrected Calcium(Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29)
- Percent Change From Baseline in Calcium Phosphorus Product(Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).)
- Percent Change From Baseline in Ionized Calcium(Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).)
- Percent Change From Baseline in Serum Phosphorus(Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).)
- Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide(Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).)
- Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide(Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).)
- Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide(Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).)
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