A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
研究概览
简要总结
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).
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
- •Subjects provides written informed consent
- •Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
- •Hemoglobin ≥ 8.5 g/dL
- •Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
- •Adequate hemodialysis three times per week
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 within the last 12 months
- •Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg
- •Serum magnesium below the lower limit of normal at screening
研究组 & 干预措施
Etelcalcetide
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
时间窗: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
次要结局
- Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period(Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment))
- Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period(The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment))
- Percent Change From Baseline in Corrected Calcium During the Efficacy Period(Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment))
- Percent Change From Baseline in Phosphorus During the Efficacy Period(Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment))