NCT02805348已完成不适用
Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 14
- 主要终点
- Change from baseline in the serum concentrations of phosphate
研究概览
简要总结
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
排除标准
- 未提供
研究组 & 干预措施
Chronic kidney disease
Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time.
干预措施: Bixalomer (Drug)
结局指标
主要结局
Change from baseline in the serum concentrations of phosphate
时间窗: Baseline and up to Month 12
Change from baseline in the corrected serum concentrations of calcium
时间窗: Baseline and up to Month 12
Change from baseline in the serum concentrations of intact parathyroid hormone
时间窗: Baseline and up to Month 12
Safety assessed by incidence of adverse events
时间窗: Up to Month 12
次要结局
未报告次要终点
研究者
研究点 (14)
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