NCT01324128已完成3 期
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia
Vifor Pharma14 个研究点 分布在 14 个国家目标入组 1,059 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,059
- 试验地点
- 14
- 主要终点
- Change in Serum Phosphorus Levels From Week 24 to Week 27
研究概览
简要总结
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.
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
- •Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
- •Stable dose of phosphate binder
- •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
Sevelamer carbonate
Active Comparator
干预措施: Sevelamer carbonate (Drug)
PA21 (2.5 g tablet)
Experimental
干预措施: PA21 (2.5 g tablet containing 500 mg iron) (Drug)
PA21-1 (1.25 g tablet)
Other
干预措施: PA21-1 (1.25 g tablet containing 250 mg iron) (Drug)
结局指标
主要结局
Change in Serum Phosphorus Levels From Week 24 to Week 27
时间窗: Week 24, Week 27
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
次要结局
- Change in Serum Phosphorus Levels From Baseline to Week 12(Week 12 post Baseline)
研究者
研究点 (14)
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