Comparison of efficacy and safety of intravenous ferric carboxymaltose versus intravenous iron (III) isomaltoside 1000 in the treatment of patients with moderate to severe iron deficiency anemia: A prospective, randomized, open-labelled, active controlled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change in mean value of hemoglobin at the end of 4 weeks after administration of study drug will be the primary efficacy outcome of the study
研究概览
简要总结
· Anemia is a major public health problem worldwide. It has significant public health implications with social and economic consequences especially in a country like India.This study might reveal one drug to be more effective or have a better safety profile than the other. This could inform physicians when choosing the most appropriate treatment for their patients with moderate to severe iron deficiency anemia. This study could provide valuable data for the first head-to-head comparison of ferric carboxymaltose and iron (III) isomaltoside 1000 for moderate to severe iron deficiency anemia. By potentially leading to more effective and well-tolerated treatment options, the study’s findings could improve patient outcomes for those suffering from moderate to severe iron deficiency anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged between 18 to 65 years inclusive of both, will be included.
- •Additionally, hemoglobin values should be greater than 6.5g/dl and less than 10g/dl, body weight should be more than 50kg, there should be a history of unresponsiveness or intolerance to oral iron therapy for at least one month before enrolment in the study.
排除标准
- •acute bleeding of more than 500ml in the past 72 hours, anemia caused predominantly by factors other than iron deficiency as decided by the investigator, known hypersensitivity to any component of ferric carboxymaltose or iron (III) isomaltoside 1000, history of hemochromatosis or any iron overload states, received intravenous iron treatment 30 days prior to enrolment in the study, received treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy and/or chemotherapy 30 days prior to enrolment in the study, raised alanine transaminase and aspartate transaminase 3 or more times above the upper limit of normal, pregnant and lactating women, history of hemoglobinopathies, thalassemia, bleeding manifestations, patients requiring dialysis, documented history of malignancy, patients with psychiatric disorders, patients not willing to participate in the study.
结局指标
主要结局
The change in mean value of hemoglobin at the end of 4 weeks after administration of study drug will be the primary efficacy outcome of the study
时间窗: 4 weeks
次要结局
- Change in the mean value of iron profile (serum iron, serum ferritin, transferrin saturation, TIBC) at the end of 4 weeks after administration of study drug will be the secondary efficacy outcome of the study(4 weeks)
- Adverse events occurring during the study period will be used to assess the safety outcomes(day 0 to day 28)
研究者
Dr Anant Khot
All India Institute of Medical Sciences Nagpur