A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patie… (NCT07687784) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia
1,366 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment
Timeframe: 6 weeks
2
Change in hemoglobin comparing one dose Ferric bepectate and two dose Ferinject treatment
. 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.