A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
研究概览
简要总结
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
详细描述
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Histological Diagnosis of Cancer
- •Hgb </= 10
- •Ongoing or Planned Chemotherapy
- •Body Weight >50kg
- •Free of Active Infection
- •Karnofsky Status 60% to 100%
排除标准
- •Active infection
- •Use of Multivitamins with iron within one week of entry
- •Myelophthisic bone marrow involvement by tumor except hematologic malignancy
- •Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
- •Use of any IV iron products within two months of study entry
- •Blood Transfusions
- •Hypoplastic bone marrow failure state
- •Acute Leukemia
- •Myeloproliferative syndrome
- •Uncontrolled hypertension
研究组 & 干预措施
Venofer + erythropoietin (responders)
干预措施: iron sucrose injection USP (Drug)
erythropoietin only (responders)
干预措施: stable erythropoietin therapy (Drug)
Venofer+erythropoietin(non-responders)
干预措施: iron sucrose injection USP (Drug)
erythropoietin only (non-responders)
干预措施: stable erythropoietin therapy (Drug)
结局指标
主要结局
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
时间窗: During Stage 2 (week 9 through week 21)
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
次要结局
未报告次要终点