A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 605
- 试验地点
- 2
- 主要终点
- Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ferumoxytol
Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).
干预措施: Ferumoxytol (Drug)
Iron Sucrose
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
干预措施: Iron Sucrose (Drug)
结局指标
主要结局
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
时间窗: Baseline (Day 1) through Week 5
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
次要结局
- Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline(From Baseline (Day 1) up to Week 5)
- Mean Change In Hemoglobin From Baseline To Week 5(Baseline (Day 1), Week 5)
- Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5(Baseline (Day 1) through Week 5)
- Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5(Baseline (Day 1), Week 5)
- Mean Change In TSAT From Baseline To Week 5(Baseline (Day 1), Week 5)