A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 349
- 主要终点
- Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
研究概览
简要总结
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
- •Men or women 18 years or older
排除标准
- •Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
研究组 & 干预措施
Genz-644470 2.4 Grams Per Day (g/day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
干预措施: Genz-644470 (Drug)
Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
干预措施: Placebo (Drug)
Genz-644470 4.8 g/day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
干预措施: Genz-644470 (Drug)
Genz-644470 7.2 g/day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
干预措施: Genz-644470 (Drug)
Sevelamer Carbonate 2.4 g/day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
干预措施: Sevelamer carbonate (Drug)
Sevelamer Carbonate 4.8 g/day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
干预措施: Sevelamer carbonate (Drug)
Sevelamer Carbonate 7.2 g/day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
干预措施: Sevelamer carbonate (Drug)
结局指标
主要结局
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
时间窗: Baseline, Day 22
次要结局
- Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)(Baseline, Day 22)
- Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22(Baseline, Day 22)
- Change From Baseline in Total Cholesterol at Day 22(Baseline, Day 22)
- Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22(Baseline, Day 22)