A Randomized, Double Blind, Parallel Group Study For Assessing The Efficacy And Safety Of Renvela® Tablets For The Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease Not On Dialysis Versus Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 202
- 试验地点
- 38
- 主要终点
- Change From Baseline in Serum Phosphorus at Week 8
研究概览
简要总结
Primary Objective:
To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in participants with chronic kidney disease not on dialysis.
Secondary Objectives:
To document the efficacy of Renvela tablets in the reduction of serum lipids (total cholesterol and low-density lipoprotein cholesterol [LDL-C]).
To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.
To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone (iPTH).
To document the efficacy of Renvela tablets in proportion of participants reaching the target serum phosphorus level 4.6 milligrams per decilitre (mg/dL) (1.47 millimoles per litre [mmol/L], inclusive).
To evaluate safety of Renvela tablets.
详细描述
The total duration of study period per participant was up to 14 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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (<=) 4.6 mg/dL (<=1.49 mmol/L).
干预措施: Placebo (Drug)
Renvela
Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
干预措施: Sevelamer Carbonate (GZ419831) (Drug)
结局指标
主要结局
Change From Baseline in Serum Phosphorus at Week 8
时间窗: Baseline, Week 8
Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward \[LOCF\] method.
次要结局
- Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8(Baseline, Week 8)
- Change From Baseline in Total Cholesterol at Week 8(Baseline, Week 8)
- Change From Baseline in Serum Phosphorus Level at Week 4(Baseline, Week 4)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)
- Change From Baseline in Calcium-Phosphorus Product at Week 8(Baseline, Week 8)
- Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8(Baseline, Week 8)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)
- Number of Participants With Clinically Significant Vital Signs Abnormalities(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)
- Number of Participants With Treatment Emergent Adverse Event(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)
- Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8(Week 8)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters(From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59)