Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Mean Change in Hemoglobin
研究概览
简要总结
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
详细描述
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.
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
- •Creatine Clearance <40 mL/min
- •Average Baseline Hemoglobin < 10.5g/dL
- •Serum Transferrin Saturation (TSAT) < 25% and Ferritin <300ng/mL
排除标准
- •Blood Transfusion within 30days
- •Uncontrolled Hypertension
- •Suffering form concommitant disease of the liver
- •Serious bacterial infection
- •Pregnancy / lactation
- •Symptomatic HIV
- •Expected to under dialysis or renal transplant during study
研究组 & 干预措施
Iron Sucrose
Iron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29
干预措施: Iron Sucrose + Erythropoietin (Drug)
Oral Iron
Oral ferrous sulfate 325 mg three times a day on Days 1 to 29.
干预措施: Oral Iron + Erythropoietin (Drug)
结局指标
主要结局
Mean Change in Hemoglobin
时间窗: Baseline and Day 43
Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Mean Change in Serum Ferritin
时间窗: Baseline and Day 43
Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
次要结局
- Clinical Success (Change in Hemoglobin)(Baseline and Day 43)
- Clinical success (change in Ferritin)(Baseline and Day 43)