NCT01419327已完成不适用
Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With 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
- 发起方
- Bayer
- 入组人数
- 3,267
- 主要终点
- Incidence of adverse drug reactions in subjects who received Fosrenol
研究概览
简要总结
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 undergoing hemodialysis who received Fosrenol for hyperphosphatemia
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
Drug (incl. Placebo)
干预措施: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet (Drug)
结局指标
主要结局
Incidence of adverse drug reactions in subjects who received Fosrenol
时间窗: After Fosrenol administration, up to 8 years
次要结局
- Timing of onset of common ADRs related to the priority survey items(After Fosrenol administration, up to 8 years)
- Effect on bones: Alkaline phosphatase over time(After Fosrenol administration, up to 8 years)
- Effect on bones: Change in bone density(After Fosrenol administration, up to 8 years)
- Cardiothoracic ratio over time(After Fosrenol administration, up to 8 years)
- PWV and ABI over time(After Fosrenol administration, up to 8 years)
- Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time(After Fosrenol administration, up to 8 years)
- Percentage of patients achieving the serum P control goal(After Fosrenol administration, up to 8 years)
研究者
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