Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 446
- 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 continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing continuous ambulatory peritoneal dialysis 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 1 year
Incidence of serious adverse events in subjects who received Fosrenol
时间窗: After Fosrenol administration, up to 1 year
次要结局
- Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol(After Fosrenol administration, up to 1 year)
- Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL](After Fosrenol administration, up to 1 year)
- Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL](After Fosrenol administration, up to 1 year)
- Clinical test value collections [calciotropic hormones, bone turnover markers](After Fosrenol administration, up to 1 year)