A phase III, randomised, single blind, comparative safety, efficacy and cost effectiveness trial of intravenous iron isomaltoside (i3R) and Ferric Carboxy Maltose (FeriumR) in subjects with iron deficiency anemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effect and cost-effectiveness of iron isomaltoside to FCM in its ability to increase Hb and Ferritin in subjects with IDA
研究概览
简要总结
Anemia is a significant public health problem involving all stages of the life cycle but is more prevalent in pregnant women and young children. Iron deficiency is the most critical contributor (>50%) to the anemia globally, to the extent that the terms iron deficiency anemia (IDA) and anemia are often used interchangeably. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.
Oral iron is considered first-line therapy for IDA because of its low cost, perceived safety profile, and ease of administration. Nonetheless, the oral iron absorption is affected by several dietary factors (particularly high phytate content in the Indian diet); also, the high incidence of gastrointestinal side effects leads to poor compliance to therapy. Parenteral iron therapy on the other hand, leads to rapid replenishment of iron stores.
Ferric carboxy maltose (FCM) has largely replaced other forms of parenteral iron preparation in India due to its acceptable dosing schedule and lower side effect profile. However, cost of treatment with FCM is a major limiting factor in its use along with notable hypophosphatemia. It is therefore, this product has been chosen as comparator in this trial which is planned to evaluate the safety,efficacy and cost effectiveness of intravenous (IV) iron isomaltoside(i3) compared to IV FCM in subjects with IDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having IDA are caused by nutritional and different aetiologies of blood loss such as abnormal uterine bleeding, gastrointestinal diseases, and bariatric procedures (gastric bypass operations.
- •Subjects with intolerance to oral iron
- •Hb ≤ 11 g/dL
- •S-ferritin < 100 ng/mL
- •Willingness to participate and sign the informed consent form.
排除标准
- •Known hypersensitivity reaction to any component of iron isomaltoside or FCM
- •Previous serious hypersensitivity reactions to any IV iron compounds
- •Previously randomized in a clinical trial with iron isomaltoside 4, Received an investigational drug within 30 days of screening
- •During the 10 days before screening; has been treated with IV iron
- •Erythropoiesis stimulating agent (ESA) treatment within 30 days before the screening visit
- •During the 30 days before screening or during the trial period; has or will require a surgical procedure that necessitates general anesthesia
- •Any non-viral infection
- •Required dialysis for treatment of CKD
- •Any other laboratory abnormality, medical condition, or psychiatric disorder which, in the opinion of the investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements.
结局指标
主要结局
To evaluate and compare the effect and cost-effectiveness of iron isomaltoside to FCM in its ability to increase Hb and Ferritin in subjects with IDA
时间窗: 4weeks, 8 weeks, 12 weeks and 24 weeks
次要结局
- To evaluate and compare the effect of iron isomaltoside to FCM on (a) Other relevant iron related biochemical parameters (b) Fatigue symptoms (c) Pharmacoeconomics