NCT00379899已完成4 期
A Randomized Study to Evaluate the Effects of Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease (CKD) Receiving 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
- 360
- 主要终点
- Percent Change From Baseline in CAC Score
研究概览
简要总结
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis
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
- •Adults with chronic kidney disease receiving hemodialysis.
- •Lab tests required at screening include Parathyroid Hormone (PTH), calcium, and phosphorus.
- •A screening coronary artery calcification score of at least 30.
排除标准
- •Subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer HCl, lanthanum) 30 days prior to screening.
- •Subjects on cinacalcet 30 days prior to screening.
- •Current or previous use of some osteoporosis medications.
- •Started or required change in cholesterol lowering medications within 30 days before screening.
- •Abnormal rhythm of the heart.
- •Parathyroidectomy done within 3 months prior to screening.
- •Anticipated parathyroidectomy or kidney transplant.
- •Current intolerance to oral medications, or inability to swallow.
- •Unstable medical condition.
- •Currently enrolled, or fewer than 30 days have passed since subject used another investigational device or drug.
- •Pregnancy or breast feeding.
研究组 & 干预措施
Control
Active Comparator
Standard of care, without use of cinacalcet.
干预措施: cinacalcet (Drug)
结局指标
主要结局
Percent Change From Baseline in CAC Score
时间窗: Baseline and Week 52
Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.
次要结局
- Change From Baseline of the Progression of AVC.(Baseline and Week 52)
- Number of Participants Achieving > 15% Progression of CAC.(52 weeks)
- Percent Change in PTH(Baseline and Week 52)
- Absolute Change in Calcium(Baseline and Weeks 44 through 52)
- Percent Change in Calcium(Baseline and Weeks 44 through 52)
- Absolute Change in Ca x P(Baseline and Weeks 44 through 52)
- Percent Change in Ca x P(Baseline and Weeks 44 through 52)
- Absolute Change in PTH(Baseline and Week 52)
- Change From Baseline in AC Score(Baseline and Week 52)
- Absolute Change in Phosphorus(Baseline and Weeks 44 through 52)
- Percent Change in Phosphorus(Baseline and Weeks 44 through 52)
研究者
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