An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
研究概览
简要总结
Primary Objective:
Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
Secondary Objective:
Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)
详细描述
10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period
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
CKD patients not on dialysis 800 mg
Sevelamer carbonate 800 mg in tabs 3 times per day with meals
干预措施: sevelamer carbonate 800mg (Drug)
CKD patients not on dialysis 2.4 g
Sevelamer carbonate 2.4 g powder carbonate per day
干预措施: sevelamer carbonate 2.4 g (Drug)
CKD patients on dialysis 800 mg
Sevelamer carbonate 800 mg in tabs 3 times per day with meals
干预措施: sevelamer carbonate 800mg (Drug)
CKD patients on dialysis 2.4 g
Sevelamer carbonate 2.4 g powder carbonate per day
干预措施: sevelamer carbonate 2.4 g (Drug)
结局指标
主要结局
The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
时间窗: up to 8 weeks
次要结局
未报告次要终点