A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 32
- 主要终点
- Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
研究概览
简要总结
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to
- Evaluate the safety and tolerability of sevelamer carbonate
- Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus
详细描述
The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.
- •The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.
排除标准
- •The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
- •The participant had a non-renal case of hyperphosphatemia.
研究组 & 干预措施
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
干预措施: Placebo (Drug)
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
干预措施: Sevelamer carbonate (Drug)
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
干预措施: Placebo (Drug)
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
干预措施: Sevelamer carbonate (Drug)
结局指标
主要结局
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
时间窗: Baseline, Week 2
Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
Treatment - Emergent Adverse Events (AEs)
时间窗: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
次要结局
- Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus(Baseline, Week 28/Early Termination)