NCT01901107已完成不适用
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis
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
- 1,078
- 主要终点
- Safety assessed by the incidence of adverse events, physical exam and lab-tests
研究概览
简要总结
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
详细描述
Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Kiklin group
干预措施: Kiklin capsules (Drug)
结局指标
主要结局
Safety assessed by the incidence of adverse events, physical exam and lab-tests
时间窗: for one year
次要结局
- Serum phosphate level(Baseline and 1, 2, 3, 6, 12 months after administration)
- Serum calcium level(Baseline and 1, 2, 3, 6, 12 months after administration)
- Intact PTH (parathyroid hormone) level(Baseline and 1, 2, 3, 6, 12 months after administration)
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