A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis
研究概览
简要总结
A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
详细描述
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
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
- •Able to understand the procedures of this trial and provide written informed consent voluntarily;
- •Age ≥ 18 years, male or female;
- •On a stable hemodialysis regimen at a frequency of two or three times per week for at least 12 weeks prior to the screening visit;
- •Serum phosphorus within the trial-required range.
排除标准
- •Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;
- •Pregnant or breastfeeding;
- •Any history of a parathyroid intervention;
- •Diarrhea or loose stools occurred within 1 week prior to randomization.
研究组 & 干预措施
JMKX003002 once daily
JMKX003002 once daily for 4 weeks
干预措施: JMKX003002 will be administered orally (Drug)
JMKX003002 twice daily
JMKX003002 twice daily for 4 weeks
干预措施: JMKX003002 will be administered orally (Drug)
Sevelamer carbonate
Sevelamer carbonate three times daily for 4 weeks
干预措施: Sevelamer carbonate (Drug)
结局指标
主要结局
To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis
时间窗: 4 weeks
The change in serum phosphorus (sP) level from baseline to the end of treatment
次要结局
未报告次要终点