One shot instead of two? new IV iron aims to simplify anemia treatment

NCT ID NCT07687784

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether a single infusion of a new intravenous iron, Ferric Bepectate, can raise hemoglobin as effectively as two infusions of the current standard treatment (ferric carboxymaltose) in adults with iron deficiency anemia. About 1,366 participants will receive either one or two doses of the new drug or two doses of the standard drug, and their blood levels will be monitored over six weeks. The study also tracks side effects to compare safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferric Bepectate (intravenous iron)
What this could lead to
If successful, this could offer a simpler, single-dose IV iron treatment for iron deficiency anemia, reducing clinic visits.
What could go wrong
This is a non-inferiority trial, so the new drug may prove no better than existing options. As with any IV iron, there is a risk of allergic reactions or infusion-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,366 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patient at least 18 years old at the time of screening 2. Patients with general iron deficiency anaemia IDA 3. Patients with serum ferritin levels ≤40 ng/mL inclusive 4. Patients with haemoglobin (Hb) levels \<10 g/dL 5. Patients ≥ 35 kg body weight 6. 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. 7. The patient is able to understand the protocol and provides informed consent to participate in the study Exclusion Criteria: 1. Pregnant or breastfeeding patients 2. Female patients not willing to use a safe method of contraception (PEARL index \<1) for the full study (screening - V5). 3. Severe physical inability, e.g., ASA physical status IV or V. 4. Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia. 5. Patients with life-threatening anaemia, defined as Hb \< 6.5 g/dL. 6. Patient is expected to require a blood transfusion within the study period or has had a blood transfusion within the 30 days prior screening. 7. Anticipated medical need for erythropoiesis-stimulating agents during the study period (screening - V5). 8. 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. 9. 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). 10. Patients with any contraindication to the investigational products, e.g., 1. known sensitivity to iron or an ingredient of the investigational products, 2. significant history of systemic allergic reactions, 3. hemochromatosis, thalassemia or TSAT \>50% as indicator of iron overload, 4. acute or chronic intoxication, 5. infection (patient on non-prophylactic antibiotics), 6. chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range. 7. chronic kidney disease, defined as GFR \<30 mL/min. 11. Primary hematologic disease. 12. Drug or alcohol abuse according to WHO definition. 13. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study. 14. Current or previous participation in another clinical trial during the last 90 days before screening. 15. Exclusion criteria according to SmPC of Ferric Carboxymaltose. 16. 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. 17. Estimated life expectancy of \<6 months or, for cancer patients, an Eastern Cooperative Oncology Group performance status \>1

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ames Medical Research

    Bragadiru, Romania

  • Colentina Clinical Hospital

    Bucharest, Romania

  • M3 Wake Research

    Dallas, Texas, 75246, United States

  • Medical Center Levitas EOOD

    Sofia, Bulgaria

  • Olympus Clinical Research

    Sugar Land, Texas, 77478, United States

  • PatientCare Clinical Research

    Houston, Texas, 77075, United States

  • PharmaSouth Research

    Coral Gables, Florida, 33146, United States

  • Sana Medical Center

    Bucharest, Romania

  • Szpital AidPort

    Skórzewo, Poland

  • The Oncology Institute

    Cluj-Napoca, Romania

  • Trialmed Melbourne

    Melbourne, Florida, 32934, United States

  • Trialmed San Antonio

    San Antonio, Texas, 78229, United States

  • Trialmed The Villages

    The Villages, Florida, 32162, United States

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