Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Maximum Measured Plasma Concentration (Cmax)
研究概览
简要总结
This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
详细描述
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 and 18 years
- •History of Chronic Renal Failure requiring HD or PD
- •Hgb </= 13 g/dL
- •Ferritin < 800 ng/ml
- •Transferrin Saturation (TSAT) < 50%
- •Receiving epoetin
排除标准
- •Known Sensitivity to Iron Sucrose
- •Severe Concomitant disease of the liver or cardiovascular system
- •Serious bacterial Infection
- •Pregnancy / Lactation
- •Active Hepatitis
- •Patients with Causes of iron deficiency other that Chronic Renal Failure
- •Blood Transfusion
- •Body Weight < 25 kilograms
- •Currently being treated for Asthma
- •Received investigational drug within last 30 days
研究组 & 干预措施
Iron Sucrose
A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes
干预措施: Iron Sucrose injection (Drug)
结局指标
主要结局
Maximum Measured Plasma Concentration (Cmax)
时间窗: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)
时间窗: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)
时间窗: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity.
Terminal Elimination Half-life (T1/2)
时间窗: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax
次要结局
- Total Body Clearance (CL)(0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes)
- Volume of Distribution (Vd)(0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes)