To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferric carboxymaltose; Iron sucrose
Intervention description: Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.; Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Intervention MeSH terms: Ferric Oxide, Saccharated
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects
Masking: None (Open Label)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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