Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- Number of responders with respect to the baseline Hb value.
研究概览
简要总结
The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.
详细描述
Anaemia in inflammatory bowel disease is mainly attributed to iron deficiency. The main cause of anaemia in IBD patients is chronic blood loss. This means that the iron storage depot in IBD patients is always low and should be replenished. Oral iron therapy is the first choice in many cases because of its safety and economy. However, in patients with gastrointestinal bleeding, the effectiveness of oral therapy is reduced. Additionally, oral iron preparations are frequently associated with gastrointestinal adverse reactions.
According to European Guidelines, the preferred route of iron supplementation in IBD is intravenous. Absolute indications for intravenous iron include severe anaemia (Hb <10 g/dL). The current study is a part of a programme investigating the efficacy and safety of FERINJECT®, a new formulation of parenteral iron (5% weight per volume iron containing ferric carboxymaltose in a solution of water for injection).
The efficacy and safety of FERINJECT® were investigated in a prospective, randomised, controlled study conducted in IBD patients. According to the results of this study, FERINJECT® provides a faster Hb response, a higher increase in iron storage and a better patient tolerance compared to oral preparations. In this study, the iron amount required was calculated according to the Ganzoni formula, where 500 mg is the amount of storage iron. To simplify the treatment and to make the treatment more effective, a new standardised dosage regimen was created. The current study is designed to assess whether this new standardised dosage regimen of i.v. FERINJECT® is as safe and effective as the currently used individually calculated dosage regimen.
The efficacy and safety of the new standardised dosage regimen of FERINJECT® will be compared with an already established, well-known treatment of IDA with iron sucrose (VENOFER®). Iron sucrose (VENOFER®) is assessed to be effective and well-tolerated in the treatment of IDA in IBD patients.
The study is a phase IIIb, multi-centre, randomised, prospective, open-label, controlled study performed at 83 study centres in 14 European countries.
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
FERINJECT® (Ferric carboxymaltose)
干预措施: Ferric carboxymaltose (Drug)
VENOFER® (Iron Sucrose)
干预措施: Iron Sucrose (Drug)
结局指标
主要结局
Number of responders with respect to the baseline Hb value.
时间窗: 12 weeks post baseline
Number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.
次要结局
- The number of non-anaemic patients at Week 12(Week 12 post baseline)
- Number of patients whose Hb increased ≥2 g/dL or who reached normal Hb levels at Week 12.(12 weeks post baseline)
- Change in disease activity (CDAI, CAI, C-reactive protein [CRP]).(12 weeks post baseline)
- The number of patients at Week 12: TfS: 20 to 50%.(12 weeks post baseline)
- The number of patients with ferritin >100 µg/L at Week 12.(12 weeks post baseline)
- Maximum increase in Hb, serum ferritin and TfS.(12 weeks post baseline)
- The number of patients at achieving Hb ≥12 (female) or ≥13 (male) g/dL and ferritin >100 µg/L at Week 12.(12 weeks post baseline)
- The number of patients withdrawal from study due to protocol procedure.(12 weeks post baseline)
- The number of responders (Hb increase ≥2 g/dL) with respect to treatment of underlying disease.(12 weeks post baseline)
- The number of patients with Hb baseline value ≤10 g/dL who achieved Hb increase ≥2 g/dL and the number of patients with Hb baseline value >10 g/dL who achieved Hb increase ≥2 g/dL.(12 weeks post baseline)
- Change in health-related quality of life (QoL) from baseline to Week 12 using the Short Form (SF)-36, version 2 and IBDQ.(12 weeks post baseline)
- The number of patients out of work due to anaemia or IBD.(12 weeks post baseline)
- Days out of hospital.(12 weeks post baseline)
- Hospitalisation rate(12 weeks post baseline)
- Adverse events: type, nature, incidence and outcome.(12 weeks post baseline)
- Vital signs (blood pressure, pulse rate and bw).(12 weeks post baseline)
- Electrocardiogram.(12 weeks post baseline)
- Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis).(12 weeks post baseline)
- Physical examination.(12 weeks post baseline)
- The number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.(12 weeks post baseline)