Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 12 to < or = 16 years
- •Parent and/or legal guardian able to give informed consent
- •Subject able to give written assent for participating in the study
- •NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
- •Hemoglobin indicative of anemia
- •Ferritin indicative of iron deficiency anemia
- •If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period
排除标准
- •Known history of hypersensitivity to any component of Venofer
- •Parenteral iron within 14 days of the screening visit
- •Dialysis dependent-CKD
- •Chronic or serious active infection
- •Pregnancy or lactation
- •Subjects with causes of iron deficiency anemia other than CKD
- •Blood transfusion within the last month or anticipated during the study
- •Body weight < 55 pounds
- •Received an investigational drug within 30 days before screening
研究组 & 干预措施
Pharmacokinetic Population
All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
干预措施: Venofer (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Time to Maximum Serum Concentration (Tmax)
时间窗: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Serum Terminal Phase Elimination Half-life (T1/2)
时间窗: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)
时间窗: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
时间窗: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Terminal Phase Elimination Rate Constant (λz)
时间窗: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
次要结局
- Total Body Clearance (Cl)(Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.)
- Initial Volume of Distribution (Vdc)(Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.)
- Volume of Distribution Based on the Terminal Phase (Vdarea)(Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.)
- Volume of Distribution at Steady State (Vdss)(Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.)
- Mean Residence Time (MRtime)(Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.)
- Number of Participants With Serious Adverse Events (SAE's)(Day of initial treatment with Venofer through 30 days after study treatment)