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

Conditions

• Iron Deficiency Anemia (IDA)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ferric Bepectate IV Injection — DRUG
  Ferric Bepectate IV Injection 50 mg iron/mL
• Ferric Carboxymaltose Injection [Ferinject] — DRUG
  Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
• Ferric Carboxymaltose Injection [Injectafer®] — DRUG
  Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart

Study Details

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.

Key Dates

First listed

Jul 7, 2026

Start date

Dec 31, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

1,366 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ferric Bepectate IV Injection single dose (US/Japan)
  Single dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 2000 mg per dose.
• Experimental: Ferric Bepectate IV Injection single dose (RoW)
  Single dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 2000 mg per dose.
• Experimental: Ferric Bepectate IV Injection two doses (US/Japan)
  Two dose experimental treatment arm for USA and Japan. 50 mg iron/mL. Up to 1000 mg per dose.
• Experimental: Ferric Bepectate IV Injection two doses (RoW)
  Two dose experimental treatment arm for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.
• Active Comparator: Injectafer (US/Japan)
  Two dose ferric carboxymaltose active comparator treatment for USA and Japan. 50 mg iron/mL. Up to 750 mg per dose.
• Active Comparator: Ferinject (RoW)
  Two dose ferric carboxymaltose active comparator treatment for rest of world. 50 mg iron/mL. Up to 1000 mg per dose.

Primary Outcome Measure

Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment [ Time Frame: 6 weeks ]

Central Contacts

• Phillip Aitken, PhD
  +6494880232
  [email protected]

Locations (7)

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