NCT06186934招募中不适用
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Serum phosphorus levels
研究概览
简要总结
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings
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
- •CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
- •Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
- •Those (or his / her legal guardian) who have agreed in writing to participate in the survey
排除标准
- •Patients with contraindications to receive Nephoxil
- •Patients with hypersensitivity to the active substance or to any of the excipients
- •Patients with hypophosphatemia
- •Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis)
- •Patients who intend to use this drug for non-approved indications
- •Patients who participated in pre-market clinical trials with Nephoxil
- •Patients who took this drug before the starting day of this survey
结局指标
主要结局
Serum phosphorus levels
时间窗: 8 weeks
Effectiveness evaluation is performed based on Serum phosphorus levels (mg/dL) before and after Nephoxil administration. We collect the most recent measurements prior to the initial administration, and measurements after at least four and eight weeks of administration of Nephoxil
次要结局
未报告次要终点
研究者
研究点 (1)
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