A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 81
- 主要终点
- Safety will be assessed based on an evaluation of related serious adverse events.
研究概览
简要总结
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder.
Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 must be 18 years of age or older,
- •on dialysis for more than 3 months,
- •require phosphate binder therapy,
- •have Medicare as their primary insurance.
排除标准
- •dysphagia,
- •swallowing disorders,
- •severe gastrointestinal motility disorders,
- •bowel obstruction.
结局指标
主要结局
Safety will be assessed based on an evaluation of related serious adverse events.
Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization.
次要结局
未报告次要终点