Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 主要终点
- Mean Change From Baseline to the Highest Hemoglobin up to Day 71
研究概览
简要总结
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
详细描述
This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin >= 9.5 and <= 11.5 g/dL.
- •Ferritin <= 500 ng/ml.
- •Serum Transferrin Saturation (TSAT) <= 25%.
- •Stable erythropoietin (EPO) Regimen for 8 weeks.
- •No iron for last 4 weeks before randomization.
排除标准
- •Known Sensitivity to Iron Sucrose.
- •Suffering concomitant severe diseases of the liver & cardiovascular system.
- •Pregnancy / Lactation.
- •Inadequate dialysis.
- •Current treatment for asthma.
- •Significant blood loss.
- •Probability of need for transfusion or transfusion within 1 week of enrollment.
- •Anticipated major surgery.
- •Hemochromatosis / hemosiderosis.
研究组 & 干预措施
Group A
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
干预措施: Venofer and stable erythropoietin (EPO) regimen (Drug)
Group B
Stable erythropoietin (EPO) dose and no supplemental iron.
干预措施: stable erythropoietin (EPO) regimen (Drug)
结局指标
主要结局
Mean Change From Baseline to the Highest Hemoglobin up to Day 71
时间窗: Change from Baseline up to Day 71
次要结局
- The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71(Change from Baseline up to Day 71)
- The Mean Change From Baseline to the Highest Ferritin up to Day 71(Change from Baseline up to Day 71)
- The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71(Change from Baseline up to Day 71)