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

NCT07687784 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: AFT-FERA-012026-527543-17-00U1111-1343-1640
• Study Type: interventional
• Target: 1,366
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Iron Deficiency Anemia (IDA)

Keywords

Iron infusion; Non-inferiority; Ferric bepectate; Ferric carboxymaltose; Ferinject; Injectafer

Outcome Measures

Primary Outcomes (3)

• 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

  6 weeks

• 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

  6 weeks

• Incidence of treatment emergent adverse events

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

  2 hours post infusion start

Secondary Outcomes (20)

• Blood hemoglobin amount

  6 weeks

• Hemoglobin change from baseline

  6 weeks

• Serum iron change from baseline

  6 weeks

• Serum ferritin change from baseline

  6 weeks

• Serum transferrin change from baseline

  6 weeks

Other Outcomes (8)

• Pooled data hemoglobin amount

  6 weeks

• Pooled data change in hemoglobin

  6 weeks

• Pooled data change in serum iron

  6 weeks

Study Arms (6)

Ferric Bepectate IV Injection single dose (US/Japan)

EXPERIMENTAL

Single dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 2000 mg per dose.

Drug: Ferric Bepectate IV Injection

Ferric Bepectate IV Injection single dose (RoW)

EXPERIMENTAL

Single dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 2000 mg per dose.

Drug: Ferric Bepectate IV Injection

Ferric Bepectate IV Injection two doses (US/Japan)

EXPERIMENTAL

Two dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 1000 mg per dose.

Drug: Ferric Bepectate IV Injection

Ferric Bepectate IV Injection two doses (RoW)

EXPERIMENTAL

Two dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.

Drug: Ferric Bepectate IV Injection

Injectafer (US/Japan)

ACTIVE COMPARATOR

Two dose ferric carboxymaltose active comparator treatment for USA and Japan. 50 mg iron/mL. Up to 750 mg per dose.

Drug: Ferric Carboxymaltose Injection [Injectafer®]

Ferinject (RoW)

ACTIVE COMPARATOR

Two dose ferric carboxymaltose active comparator treatment for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.

Drug: Ferric Carboxymaltose Injection [Ferinject]

Interventions

Ferric Bepectate IV Injection DRUG

Ferric Bepectate IV Injection 50 mg iron/mL

Also known as: Feramyl, Ferric bepectate

Ferric Bepectate IV Injection single dose (RoW); Ferric Bepectate IV Injection single dose (US/Japan); Ferric Bepectate IV Injection two doses (RoW); Ferric Bepectate IV Injection two doses (US/Japan)

Ferric Carboxymaltose Injection [Ferinject] DRUG

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

Also known as: Ferinject

Ferinject (RoW)

Ferric Carboxymaltose Injection [Injectafer®] DRUG

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

Also known as: Injectafer

Injectafer (US/Japan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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),

Sponsors & Collaborators

• AFT Pharmaceuticals, Ltd.: lead
• HungaroTrial: collaborator

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ioana Stanescu, Phil.Lic., MSc.

  AFT Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Phillip Aitken, PhD

CONTACT

+6494880232; phillip.aitken@aftpharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, active-controlled, open-label study

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07