IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 27
- 主要终点
- Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
研究概览
简要总结
Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.
详细描述
This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.
- •Subjects with non-myeloid malignancies
- •Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.
- •Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.
- •Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%
- •Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-
- •Life expectancy of at least 6 months.
- •Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.
排除标准
- •Previous participation in a ferric carboxymaltose clinical trial.
- •Known hypersensitivity reaction to any component of ferric carboxymaltose.
- •Subjects with overt bleeding
- •Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents).
- •Subjects on erythropoiesis-stimulating agents.
- •Requiring dialysis for the treatment of chronic kidney disease.
- •Any non-viral infection.
- •Known positive hepatitis with evidence of active disease.
- •Received an investigational drug within 30 days of screening.
- •Alcohol or drug abuse within the past 6 months.
- •Hemochromatosis or other iron storage disorders.
- •Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- •Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).
研究组 & 干预措施
Injectafer
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
干预措施: Injectafer (Drug)
Normal Saline
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
干预措施: Normal Saline (Other)
结局指标
主要结局
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
时间窗: Week 3 to Week 18
The following participants will be considered to have met the primary endpoint: * Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. * Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. * Participants who have a non-study intervention prior to Week 18. * Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
次要结局
- Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention(Baseline to Week 18)
- Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit(Baseline to Week 18)
- Percentage of Participants Who Received Nonstudy Intervention(Baseline to week 18)
- Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention(Baseline to week 18)
- Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention(Baseline to Week 18)
- Percentage of Participants Requiring a Blood Transfusion(Baseline to week 18)
- Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention(Baseline to Week 18)
- Correlation of Change in Hemoglobin With Baseline Hepcidin Level(Baseline to Week 18.)
- Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.(Baseline to Week 15)
- Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18(From Baseline to Week 18)
- Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18(Baseline to Week 18)