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Iron Deficiency Anemia (IDA)Phase 3NCT07687784

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

A Phase 3 study testing Ferric Bepectate IV Injection, Ferric Carboxymaltose Injection [Ferinject] and Ferric Carboxymaltose Injection [Injectafer®] in people with Iron Deficiency Anemia (IDA), run by AFT Pharmaceuticals, Ltd. at 13 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Iron Deficiency Anemia (IDA)
What is being tested?
Ferric Bepectate IV Injection, Ferric Carboxymaltose Injection [Ferinject] and Ferric Carboxymaltose Injection [Injectafer®]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,366 participants
Where
13 sitesin 4 countries
Study dates
Dec 2026to Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 24Show fewer
  • 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

Trial locations and contacts

13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Phillip Aitken, PhD contact

+6494880232

phillip.aitken@aftpharm.com

13 sites in 4 countries

United States7 sites

  • PharmaSouth Research

    Coral Gables, Florida, 33146

    Francisco Quintana, MD

  • M3 Wake Research

    Dallas, Texas, 75246

    Ralph Cox, MD

  • PatientCare Clinical Research

    Houston, Texas, 77075

    Anibal Rossel, MD

  • Trialmed Melbourne

    Melbourne, Florida, 32934

    Murray A Kimmel, MD

  • Trialmed San Antonio

    San Antonio, Texas, 78229

    Tahira Alves, MD

  • Olympus Clinical Research

    Sugar Land, Texas, 77478

    Harish Thakker, MD

  • Trialmed The Villages

    The Villages, Florida, 32162

    Angela Okolie, MD

Other trials in United States

Romania4 sites

  • Ames Medical Research

    Bragadiru

    Carastoian Nicoleta, MD

  • Colentina Clinical Hospital

    Bucharest

    Daniela Georgescu, MD

  • Sana Medical Center

    Bucharest

    Adrian Sarbu, MD

  • The Oncology Institute

    Cluj-Napoca

    Ciprian Tomuleasa, MD

Other trials in Romania

Bulgaria1 site

  • Medical Center Levitas EOOD

    Sofia

    Boris Krumov, MD

Other trials in Bulgaria

Poland1 site

  • Szpital AidPort

    Skórzewo

    Michal Kwiatek, MD

Other trials in Poland

About this study

Official title: A Multicentre, Prospective, Randomized, Active-Controlled, Open-Label, Phase III Study to Test the Non-Inferiority of Intravenous Injection of Ferric Bepectate IV Injection Compared to Ferric Carboxymaltose for Treatment of Patients With Iron Deficiency Anaemia (IDA)

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.

Read the detailed description

Iron is essential for the normal functioning of a human body. Iron deficiency anemia (IDA) occurs when blood lacks adequate healthy red blood cells, preventing adequate distribution of oxygen throughout the tissue of the body.

IDA, if left uncorrected, may result in complications such as extreme fatigue, weakness, chest pain, shortness of breath, irregular heartbeats or even heart failure in some cases, in addition to reducing the overall quality of life of a patient. Iron supplementation can effectively treat IDA. An iron-rich diet is known to enhance iron levels, however supplementation is limited by the bio-availability of iron compounds. Oral iron treatment is the most common form of therapy for iron supplementation. However, oral iron supplementation is not ideal for all patients, as adverse events are common, and some patients also fail to respond. Common adverse events (AEs) include significant gastrointestinal discomfort, metallic taste and staining of teeth, resulting in patience discontinuing the treatment. Intravenous (i.v) iron therapy is regarded as a safe method to correct anemia resulting from several conditions that avoids many of the gastrointestinal AEs common with oral iron supplementation.

Ferric carboxymaltose is an established i.v iron formulation approved to treat IDA in Europe and USA. In patients with high iron need, ferric carboxymaltose requires at least two injections, at least 7 days apart. A new i.v. iron formulation has been developed, Ferric Bepectate IV Injection. Ferric Bepectate IV Injection has the potential to be dosed at higher volumes compared to other i.v. iron formulations, allowing for patients with high iron needs to only undergo a single infusion, reducing the medical burden on both the patient and the medical system, and providing a rapid improvement to IDA and associated symptoms.

The current phase 3 study aims to compare Ferric Bepectate IV Injection with two Ferric carboxymaltose formulations (comparators: Ferinject® and Injectafer®) to determine non-inferiority between the Ferric Bepectate IV Injection single dose administration and the current approved dosing for the comparators. A comparison between treatments of the change of hemoglobin (Hb) from baseline after 6 weeks will be the primary outcome. Safety of each treatment will also be assessed to determine superiority, by examining the number of adverse events in the 2 hour period following the beginning of infusion. Key secondary safety endpoints will assess the difference in volume-corrected urine iron after i.v administration, and incidence of hypophosphatemia during the 6 week follow-up period.

A two-dose administration of Ferric Bepectate IV Injection will also be assessed to compare efficacy, tolerance, and safety with the single-dose administration and the comparators.

Being tested
Ferric Bepectate IV Injection, Ferric Carboxymaltose Injection [Ferinject], Ferric Carboxymaltose Injection [Injectafer®]
Keywords
Iron infusion, Non-inferiority, Ferric bepectate, Ferric carboxymaltose, Ferinject, Injectafer
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric Bepectate IV InjectionDrug

    Also called Feramyl, Ferric bepectate

    Ferric Bepectate IV Injection 50 mg iron/mL

  • Ferric Carboxymaltose Injection [Ferinject]Drug

    Also called Ferinject

    Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart

  • Ferric Carboxymaltose Injection [Injectafer®]Drug

    Also called Injectafer

    Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart

Study groups in NCT07687784
Study groupRoleWhat they receive
Ferric Bepectate IV Injection single dose (US/Japan)ExperimentalSingle dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 2000 mg per dose.
Receives: Drug: Ferric Bepectate IV Injection
Ferric Bepectate IV Injection single dose (RoW)ExperimentalSingle dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 2000 mg per dose.
Receives: Drug: Ferric Bepectate IV Injection
Ferric Bepectate IV Injection two doses (US/Japan)ExperimentalTwo dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 1000 mg per dose.
Receives: Drug: Ferric Bepectate IV Injection
Ferric Bepectate IV Injection two doses (RoW)ExperimentalTwo dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
Receives: Drug: Ferric Bepectate IV Injection
Injectafer (US/Japan)Active comparatorTwo dose ferric carboxymaltose active comparator treatment for USA and Japan. 50 mg iron/mL. Up to 750 mg per dose.
Receives: Drug: Ferric Carboxymaltose Injection [Injectafer®]
Ferinject (RoW)Active comparatorTwo dose ferric carboxymaltose active comparator treatment for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
Receives: Drug: Ferric Carboxymaltose Injection [Ferinject]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment

    The mean change in blood hemoglobin from baseline at week 6 showing non-inferiority between the treatment groups Ferric Bepectate IV Injection (single dose) and Injectafer

    Measured: 6 weeks

  2. Change in hemoglobin comparing one dose Ferric bepectate and two dose Ferinject treatment

    The mean change in blood hemoglobin from baseline at week 6 showing non-inferiority between the treatment groups Ferric Bepectate IV Injection (single dose) and Ferinject

    Measured: 6 weeks

  3. Incidence of treatment emergent adverse events

    Incidence of treatment emergent adverse events (TEAE) during the 2 hours following the start of infusion

    Measured: 2 hours post infusion start

Secondary outcomes (19)

  1. Blood hemoglobin amount

    Mean blood hemoglobin at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.

    Measured: 6 weeks

  2. Hemoglobin change from baseline

    Mean change in blood hemoglobin from baseline to weeks 1, 2, 4 and 6.

    Measured: 6 weeks

  3. Serum iron change from baseline

    Mean change in serum iron from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.

    Measured: 6 weeks

  4. Serum ferritin change from baseline

    Mean change in serum ferritin from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.

    Measured: 6 weeks

  5. Serum transferrin change from baseline

    Mean change in serum transferrin from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.

    Measured: 6 weeks

  6. Serum transferrin saturation change from baseline

    Mean change in serum transferrin saturation (TSAT) from baseline at weeks 1, 2, 4 and 6 timepoints. Compared between all treatment groups.

    Measured: 6 weeks

  7. Response Rate

    Proportion of patients with normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).

    Measured: 6 weeks

  8. Time to normalization of hemoglobin

    Time to normalization normalization (defined in WHO classification) of hemoglobin at week 6 (Response Rate).

    Measured: 6 weeks

  9. Change in fatigue symptoms

    Change in fatigue symptoms from baseline at week 6 measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue). A final score of 0-52 is calculated, where a high score indicates better quality of life.

    Measured: 6 weeks

  10. Incidence of hypophosphatemia

    Incidence of hypophosphatemia (serum phosphate < 2 mg/dL) at any time during the follow-up period (baseline - week 6)

    Measured: 6 weeks

  11. Volume-corrected urine iron amount

    Pre- and post-difference of volume-corrected urine iron levels measured before and in the first urine after the end of i.v. administration, (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine)

    Measured: 2 hours

  12. Adverse event severity

    Severity of treatment emergent adverse events (TEAEs) during the 2 hours following infusion start

    Measured: 2 hours following infusion start

  13. Adverse event incidence and severity

    Incidence and severity of TEAEs during the entire study period (screening - V5)

    Measured: 6 weeks

  14. Treatment related adverse event incidence and severity

    Incidence and severity of AEs classified as possibly, probably or definitely related to the study drug (Treatment related adverse events; TRAE) during the study period (screening - V5)

    Measured: 6 weeks

  15. Incidence of injection/infusion site reactions and hypersensitivity reactions

    Incidence of injection/infusion site reactions and hypersensitivity reactions

    Measured: 2 hours following infusion start

  16. Change in serum phosphate

    Mean change in serum phosphate from baseline to week 6

    Measured: 6 weeks

  17. Change in serum calcium

    Mean change in serum calcium from baseline to week 6

    Measured: 6 weeks

  18. ECG changes

    Electrocardiogram (ECG) changes from baseline at week 1, 2, 4 and 6. The ECG will specifically assess the following parameters:

    • Heart Rate
    • QT interval
    • ST depression
    • T wave inversion
    • Prescence of tachycardia
    • Left ventricular hypertrophy
    • Investigator interpretation (normal, abnormal NCS, abnormal CS)

    Measured: 6 weeks

  19. ECG and Hemoglobin relationship

    Relation between electrocardiogram (ECG) investigator interpretation (normal, abnormal NCS, abnormal CS) and hemoglobin at baseline and End of Treatment

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, active-controlled, open-label study
Masking
None (open label)
Enrolment
1,366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07687784
Sponsor's protocol ID
AFT-FERA-01
Other IDs
2026-527543-17-00, U1111-1343-1640
Status last verified
Aug 2026
First submitted
30 Jun 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: The results of the study may be published in a scientific journal, however individual patient data will not be used, rather data will be provided as descriptive statistics (mean, median, IQR) as required.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferric Bepectate IV Injection, Ferric Carboxymaltose Injection [Ferinject] and Ferric Carboxymaltose Injection [Injectafer®] in people with Iron Deficiency Anemia (IDA), run by AFT Pharmaceuticals, Ltd. at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Romania, Bulgaria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phillip Aitken, PhD (+6494880232, phillip.aitken@aftpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07687784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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