To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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