NCT00117052已完成3 期
SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 673
- 主要终点
- Number of subjects with PTH less than or equal to 300pg/mL
研究概览
简要总结
The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL [2.1 mmol/L]
排除标准
- •Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
研究组 & 干预措施
Post-dialysis meal
Active Comparator
Cinacalcet is administered with a post-dialysis meal
干预措施: cinacalcet (Drug)
During dialysis visit
Active Comparator
Cinacalcet is given during the dialysis visit
干预措施: cinacalcet (Drug)
结局指标
主要结局
Number of subjects with PTH less than or equal to 300pg/mL
时间窗: 21 week dose optimisation phase
次要结局
- Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes(Dose Optimisation phase 21 weeks)
- Safety of cinacalcet(21 weeks)
研究者
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