A Multicenter Registry to Evaluate the Long-term Safety and Tolerability of Maintenance Treatment With Iron Sucrose (Venofer) in Pediatric Patients Ages ≥ 2 to ≤ 17 Years With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Treatment- emergent adverse events (TEAE)
研究概览
简要总结
The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.
详细描述
This will be a multicenter, observational, prospective registry collecting long-term (12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent (NDD) chronic kidney disease (CKD).
Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of Venofer administered on study) will be collected via site entry of data into a web-based system. Each research investigator will be responsible for entering adverse event information on the appropriate clinical research form as well as reporting such events to the sponsor.
Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have safety data recorded at the 12 month time point).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 2 to less than or equal to 17 years
- •Subjects must have a diagnosis of either NDD-CKD, PD-CKD or HD-CKD
- •Dialysis patients must be on a stable periotoneal (PD) or hemodialysis (HD) regimen for 1 month
- •Patient agrees to participate in the registry (i.e., provide adverse event information) for 12 months
排除标准
- 未提供
结局指标
主要结局
Treatment- emergent adverse events (TEAE)
时间窗: 1st Venofer dose through 12 month observation
Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation
次要结局
未报告次要终点