The goal of this clinical trial is to see if a new intravenous iron formulation (Ferric Bepectate IV Injection) can treat adult patients with iron deficiency anemia (IDA) by increasing blood hemoglobin (Hb) as an established formulation (Ferric carboxymaltose). It will also learn about the safety of Ferric Bepectate IV Injection. The main questions it aims to answer are:
* Does hemoglobin increase by the same amount 6 weeks after each treatment? * What medical problems do participants have when being treated with the drug? Researchers will compare single dose treatment plans of Ferric Bepectate to double dose treatment plans of both Ferric Bepectate and Ferric carboxymaltose.
Participants and researchers will know which drug they are being provided (open-label). Participants will visit the clinic 5 times over 6 weeks for checkups, blood tests and questionaries. The first two visits will be seven days apart and include the two doses of iron treatment.
Male or female patient at least 18 years old at the time of screening
Patients with general iron deficiency anaemia IDA
Patients with serum ferritin levels ≤40 ng/mL inclusive
Patients with haemoglobin (Hb) levels <10 g/dL
Pregnant or breastfeeding patients
Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study (screening - V5).
Severe physical inability, e.g., ASA physical status IV or V.
Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia.
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Treatment groupsSee each treatment group below.
AFT Pharmaceuticals, Ltd.
Lead sponsor
HungaroTrial
Collaborator