One shot instead of two? new IV iron aims to simplify anemia treatment
NCT ID NCT07687784
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,366 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
13 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ames Medical Research
Bragadiru, Romania
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Colentina Clinical Hospital
Bucharest, Romania
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M3 Wake Research
Dallas, Texas, 75246, United States
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Medical Center Levitas EOOD
Sofia, Bulgaria
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Olympus Clinical Research
Sugar Land, Texas, 77478, United States
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PatientCare Clinical Research
Houston, Texas, 77075, United States
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PharmaSouth Research
Coral Gables, Florida, 33146, United States
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Sana Medical Center
Bucharest, Romania
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Szpital AidPort
Skórzewo, Poland
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The Oncology Institute
Cluj-Napoca, Romania
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Trialmed Melbourne
Melbourne, Florida, 32934, United States
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Trialmed San Antonio
San Antonio, Texas, 78229, United States
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Trialmed The Villages
The Villages, Florida, 32162, United States
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Other studies related to the condition(s) this trial covers.
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