Clinical Trial

A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia

Not Yet Recruiting Phase 3
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-30.
Trial Details
NCT Number NCT07687784
Lead Sponsor AFT Pharmaceuticals, Ltd.
Collaborators: HungaroTrial
Conditions Iron Deficiency Anemia (IDA)
Enrollment 1,366 participants
Start Date 2026-12
Primary Completion 2028-06 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-08