An Open-label, Randomised Controlled Multi-centre Study to Assess the Impact of Ferric Carboxymaltose in Correcting Iron Deficiency Anaemia Compared With Venofer® (Iron Sucrose) in Chinese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8
研究概览
简要总结
The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in the Chinese population.
详细描述
This is an open-label, randomised controlled study to assess the impact of FCM in correcting iron deficiency anaemia compared with Venofer™ (IS).
All subjects, after providing written informed consent and meeting the eligibility assessments, will receive a first dose of IV iron as either FCM or IS. A total of approximately 368 subjects (184 per group) will be enrolled. All subjects will have iron deficiency anaemia as measured by haemoglobin (Hb), serum ferritin and transferrin saturation (TSAT) at screening.
Ferric carboxymaltose will be administered as either a diluted infusion or undiluted injection (at Investigator discretion) and IS will be administered as a slow intravenous injection at a rate of 1 ml undiluted solution per minute (with each single injection of 200 mg iron) or by drip infusion. Note, for subjects randomised to receive IS dosing visits are required three times a week to achieve total iron repletion dosing as calculated using the Ganzoni formula.
For subjects randomised to FCM, the total iron requirements will be calculated at screening based on the screening Hb and subject weight. Dosing will be at baseline and, if required, at day 8 and day 15. All subjects will attend study visits at screening, baseline and thereafter at Weeks 2, 4 and 6. All subjects will attend an end of study visit (at Week 8 - or earlier if discontinued prematurely).
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
- •At least 18 years of age
- •Hb <11 g/dL (females) or Hb <12 g/dL (males) at the screening visit
- •Serum ferritin <100 ng/mL for subjects with underlying inflammatory disease (e.g., inflammatory bowel disease (IBD), chronic kidney disease (CKD) or chronic heart failure (CHF), as determined by high sensitive C-reactive protein [hsCRP] levels above the normal range) otherwise ≤14 ng/mL in subjects with no apparent underlying inflammatory disease (as determined by hsCRP levels within normal range) at the screening visit
- •Transferrin Saturation (TSAT) <16% (any subject) at the screening visit
- •Microcytic, hypochromic anaemia defined as: a) Mean corpuscular Hb concentration (MCHC) <32%; b) Mean corpuscular volume (MCV) < 80 fL; c)Mean corpuscular Hb (MCH) <27 pg
- •Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments
- •Before any study-specific procedure is conducted, the appropriate written informed consent must be obtained
排除标准
- •Subject has known hypersensitivity to any of the products to be administered during dosing
- •Any history of iron storage diseases such as haemochromatosis
- •Any history or clinical findings of iron utilisation disorders such as sideroachrestic anaemia
- •Known haemoglobinopathy (e.g. thalassaemia)
- •Any history or clinical findings of anaemia associated with: a) Haematuria b) Vitamin B12 or folic acid deficiency that requires treatment (subjects can be included after deficiency is corrected)
- •Any allergic predispositions, i.e. any history of asthma or atopic allergy. This includes drug allergies.
- •Planned surgery with anticipated blood loss (defined as Hb drop >2 g/dL) in the 3 months post randomisation
- •Subject has known malignancy (with or without current treatment), except basal cell or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
- •Haemodialysis (current or planned within the next 3 months)
- •History of IV iron therapy, erythropoiesis stimulating agent (ESA) therapy and/or blood transfusion in previous 4 weeks prior to screening, and oral iron or oral iron-containing products including Chinese herbal medicines (>75mg iron/day) in the 7 days prior to screening
- •Body weight <35 kg
- •Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above 3 times the upper limit of the normal range
- •Known human immunodeficiency virus infection, acquired immunodeficiency syndrome, tuberculosis
- •Known active hepatitis B or C or other active infection (acute or chronic)
- •Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s)
- •Subject is pregnant or is breast feeding
- •Female subject of childbearing potential not using adequate contraceptive methods during the study and for up to 1 month after the last dose of the study medication. Adequate contraceptive methods are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post-menopausal, defined as amenorrhoea for at least 12 months
- •Male subjects planning to father a child within 7 days from the last study drug administration.
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures and/or other reason(s) that render subject not appropriate for study participation in the opinion of the treating physician
研究组 & 干预措施
Ferric carboxymaltose (FCM)
Subjects treated with FCM given by IV injection or drip infusion
干预措施: Ferric carboxymaltose (Drug)
Iron sucrose (IS)
Subjects treated with IS given by IV injection or drip infusion
干预措施: Iron sucrose (Drug)
结局指标
主要结局
Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8
时间窗: From baseline at any time up to Week 8
Haemoglobin (Hb)
次要结局
- Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8(From Baseline to weeks 2, 4, 6 and 8)
- Change in Hb From Baseline to Weeks 2, 4, 6, and 8(From Baseline to weeks 2, 4, 6 and 8)
- Participants With Iron Deficiency Correction Over Time by Treatment(From Baseline to Weeks 2, 4, 6 and 8)
- Change in TSAT From Baseline to Weeks 2, 4, 6 and 8(From Baseline to weeks 2, 4, 6 and 8)
- Body Weight at Baseline and Week 8(Baseline and week 8)
- Heart Rate at Baseline and Weeks 2, 4, 6 and 8(Baseline and weeks 2, 4, 6 and 8)
- Body Temperature at Baseline and Weeks 2, 4, 6 and 8(Baseline and weeks 2, 4, 6 and 8)
- Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8(From Baseline to Weeks 2, 4, 6 and 8)
- Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8(From Baseline to weeks 2, 4, 6 and 8)
- Participants With Any Treatment Emergent Adverse Event (TEAE)(From Baseline to the End of the study (week 8))
- Blood Pressure at Baseline and Weeks 2, 4, 6 and 8(Baseline and weeks 2, 4, 6 and 8)