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

NCT07687784 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1366

Last updated 2026-07-08

No results posted yet for this study

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)

Interventions

DRUG

Ferric Bepectate IV Injection

Ferric Bepectate IV Injection 50 mg iron/mL

DRUG

Ferric Carboxymaltose Injection [Ferinject]

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

DRUG

Ferric Carboxymaltose Injection [Injectafer®]

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

Sponsors & Collaborators

  • HungaroTrial

    collaborator UNKNOWN

  • AFT Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Ioana Stanescu, Phil.Lic., MSc. · AFT Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-06-30
Completion
2028-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687784 on ClinicalTrials.gov