NCT00446329终止4 期
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Papageorgiou General Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
研究概览
简要总结
The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.
The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age older than 18 yrs
- •On hemodialysis for at least 3 months (thrice weekly)
- •iPTH >300pg/ml or histological evidence of secondary hyperparathyroidism
- •Calcium > 8.1 mg/dl
排除标准
- •Unstable clinical condition
结局指标
主要结局
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
时间窗: one year period
次要结局
未报告次要终点
研究者
Efstathios Mitsopoulos
Nephrologist
Papageorgiou General Hospital
研究点 (2)
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