A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia
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.
Timeline
- Start
- 2026-12
- Primary completion
- 2028-06
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric Bepectate | Unknown | 1000 mg | Intravenous |
| Subject | Ferric Bepectate | Unknown | 2000 mg | Intravenous |
| Comparator | Ferric carboxymaltose | Other / unclassified | 750 mg | Intravenous |
| Comparator | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |