A Phase IV, Open-Label, Multi-Center Trial Evaluating the Efficacy of Fosrenol Compared to Existing Therapy in Adults With End Stage Renal Disease Treated for Hyperphosphatemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 2,500
- 主要终点
- Pre-dialysis serum phosphorus levels at 12 weeks
研究概览
简要总结
The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.
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
- •Patients with ESRD who currently require treatment for hyperphosphatemia
排除标准
- •Female patient who is pregnant or lactating
- •Patient has used any investigational product within 30 days of screening
结局指标
主要结局
Pre-dialysis serum phosphorus levels at 12 weeks
时间窗: Week 12
Patient satisfaction questionnaire at 12 weeks
时间窗: Week 12
7 question patient satisfaction questionnaire for participants to respond to how strongly they agree or disagree with their experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.
Physician satisfaction questionnaire at 12 weeks
时间窗: Week 12
6 question physician satisfaction questionnaire for physicians to respond to how strongly they agree or disagree with their patient's experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.
Patient preference questionnaire at 12 weeks
时间窗: Week 12
6 question patient preference questionnaire for participants to respond to whether they preferred the medication they received during this clinical trial or their previous medication.
Physician preference questionnaire at 12 weeks
时间窗: Week 12
7 question physician preference questionnaire for physicians to respond to whether they preferred the medication administered during this clinical trial or their patient's previous medication.
次要结局
未报告次要终点