NCT01181531已完成4 期
A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 312
- 主要终点
- Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
研究概览
简要总结
The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years at screening
- •Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening
- •Informed consent provided by the study candidate
- •For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory
排除标准
- •Parathyroidectomy in the 12 weeks before the date of informed consent
- •History of seizure within 12 weeks prior to randomization
- •Scheduled for kidney transplant
- •Parathyroidectomy anticipated within the next 6 months
- •Liver function tests > than 2 x the Upper Limit of Normal
- •Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial
- •Subject has previously enrolled in this study
- •Other investigational procedures are excluded
- •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- •Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment
- •Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment
- •Subject has known sensitivity or intolerance to any of the protocol required therapies
- •Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge
- •Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
研究组 & 干预措施
Traditional Vitamin D Therapy
Active Comparator
干预措施: Traditional Vitamin D Therapy (Drug)
Cinacalcet
Experimental
干预措施: Cinacalcet (Drug)
结局指标
主要结局
Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
时间窗: Baseline to week 40-52
Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52
次要结局
- Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)(Baseline to week 40-52)
- Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)(week 40-52)
研究者
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