An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 659
- 试验地点
- 14
- 主要终点
- Change From Baseline and Levels at Each Time Point for Serum Calcium
研究概览
简要总结
This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.
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
- •Subjects who have completed treatment in Protocol PA-CL-05A
- •Written Informed Consent
排除标准
- •Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
- •Other significant medical conditions
- •Pregnancy
研究组 & 干预措施
PA21
干预措施: PA21 (2.5 g tablet containing 500 mg iron) (Drug)
Sevelamer carbonate
干预措施: Sevelamer carbonate (Drug)
结局指标
主要结局
Change From Baseline and Levels at Each Time Point for Serum Calcium
时间窗: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
时间窗: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
时间窗: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
次要结局
未报告次要终点