An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hyperphosphatemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 657
- 试验地点
- 105
- 主要终点
- Stage 1: Control or not the level of serum phosphate
研究概览
简要总结
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.
详细描述
High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposites in the body and blood-vessel disease.
Current guidelines indicate that blood phosphorous levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
This is a 2-stage re-randomization design where Stage 1 is a randomized, open label comparison between fermagate and lanthanum carbonate (in a non-inferiority design) and Stage 2 is a randomized double blind comparison between fermagate and placebo (in a superiority design).
Objectives at Stage 1:
Primary Objective:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Magnesium iron hydroxycarbonate
干预措施: Magnesium iron hydroxycarbonate (Drug)
Lanthanum carbonate
干预措施: Lanthanum carbonate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Stage 1: Control or not the level of serum phosphate
时间窗: Within the treatment period
Stage 2: Change from treated baseline in mean serum phosphate
时间窗: At 4 weeks
次要结局
- Stage 1: Change from baseline in mean serum phosphate(End of 3 months treatment in maintenance period)
- Stage 2: Change from treated baseline in mean serum phosphate(At weeks 1, 2 and 3)
- Stage 2: Change from treated baseline in Ca, Ca-phosphate product and PTH levels(At the end of weeks 1, 2, 3 and 4)
- Stage 1: Change from baseline in calcium, calcium phosphate product and PTH level(End of 3 months treatment in maintenance period)