An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Hypocalcemia
研究概览
简要总结
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
详细描述
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.
The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.
Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
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
- 28 Days 至 2189 Days（Child）
- 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
Cinacalcet
Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.
After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.
All participants also received standard of care, which may have included vitamin D sterols.
干预措施: Cinacalcet hydrochloride (Drug)
Cinacalcet
Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.
After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.
All participants also received standard of care, which may have included vitamin D sterols.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Percentage of Participants With Hypocalcemia
时间窗: 26 weeks
Hypocalcemia was defined as corrected serum calcium levels \< 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to \< 2 years, and \< 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to \< 6 years at any time during the study.
次要结局
- Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements(26 weeks)
- Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study(26 weeks)
- Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements(26 weeks)
- Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study(26 weeks)
- Percent Change From Baseline in Corrected Serum Calcium(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Percent Change From Baseline in Serum Phosphorous(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet(Week 12)
- Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study(26 weeks)
- Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet(Week 12)