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

Starting soon · Phase 3

Conditions studied: Iron Deficiency Anemia (IDA)

In brief

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.

Key facts

Study ID

NCT07687784

Run by

AFT Pharmaceuticals, Ltd.

People needed

1366

Starts

2026-12-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients ≥ 35 kg body weight
• The patient has adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum creatinine level of less than 2 mg/dL.
• The patient is able to understand the protocol and provides informed consent to participate in the study

You may not qualify if…

• 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.
• Patients with life-threatening anaemia, defined as Hb < 6.5 g/dL.
• Patient is expected to require a blood transfusion within the study period or has had a blood transfusion within the 30 days prior screening.
• Anticipated medical need for erythropoiesis-stimulating agents during the study period (screening - V5).
• Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage whichever occurs earlier in routine care.
• Patient has undergone a surgical procedure during the 30 days prior to screening, and/or is expected to undergo a surgical procedure during the study period (screening - V5).
• Patients with any contraindication to the investigational products, e.g.,
• known sensitivity to iron or an ingredient of the investigational products,
• significant history of systemic allergic reactions,
• hemochromatosis, thalassemia or TSAT >50% as indicator of iron overload,
• acute or chronic intoxication,
• infection (patient on non-prophylactic antibiotics),
• chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range.
• chronic kidney disease, defined as GFR <30 mL/min.
• Primary hematologic disease.
• Drug or alcohol abuse according to WHO definition.
• Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
• Current or previous participation in another clinical trial during the last 90 days before screening.
• Exclusion criteria according to SmPC of Ferric Carboxymaltose.
• The following concomitant treatments prescribed by a physician for non-iron deficiency anaemia (e.g., known vitamin B12 or folate deficiency), hemoglobinopathy, or unexplained anaemia are not allowed during the study and 24 weeks before screening: Erythropoiesis-stimulating agents, vitamin B12, Folic acid or other I.V. or oral iron products.
• Estimated life expectancy of <6 months or, for cancer patients, an Eastern Cooperative Oncology Group performance status >1

Full record on ClinicalTrials.gov

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