Multicenter, Open, Prospective, 48 Weeks, Observational Study in the Real-world to Evaluate the Safety and Efficacy of Nephoxil Capsule for Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- LG Chem
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.
详细描述
This study is a prospective observational study, and only observable information is collected during Visits 1 to 13 of the subjects' routine outpatient visits. Therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator.
The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. During the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 19 years of age or older as of the ICF date
- •CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator
- •Patients who voluntarily decide to participate in this study and complete the ICF
排除标准
- •Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
- •Those who require concomitant administration of aluminum-containing medication
- •Others determined by the investigator to be unsuitable for participation in this study
研究组 & 干预措施
low-dose group
initial dose 1.5 g/day
干预措施: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) (Drug)
standard-dose group
initial dose 4 g/day
干预措施: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) (Drug)
结局指标
主要结局
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
时间窗: 48 weeks
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
次要结局
- Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)(40 ~ 48 weeks)
- Mean change from baseline to week 48 in serum phosphorus level(48 weeks)
- Initial dose retention period(Up to 48weeks)