A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Ferric Bepectate IV Injection: Ferric Bepectate IV Injection 50 mg iron/mL
Ferric Carboxymaltose Injection [Ferinject]: Ferric carboxymaltose (Ferinject®) 50 mg iron/mL in two doses 7-9 days apart
Ferric Carboxymaltose Injection [Injectafer®]: Ferric carboxymaltose (Injectafer®) 50 mg iron/mL in two doses 7-9 days apart
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.
Eligibility
Primary outcome measure(s)
- Change in hemoglobin comparing one dose Ferric bepectate and two dose Injectafer treatment — 6 weeks
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 - Change in hemoglobin comparing one dose Ferric bepectate and two dose Ferinject treatment — 6 weeks
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 - Incidence of treatment emergent adverse events — 2 hours post infusion start
Incidence of treatment emergent adverse events (TEAE) during the 2 hours following the start of infusion
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| PharmaSouth Research | Coral Gables | Florida | |
| Trialmed Melbourne | Melbourne | Florida | |
| Trialmed The Villages | The Villages | Florida | |
| M3 Wake Research | Dallas | Texas | |
| PatientCare Clinical Research | Houston | Texas | |
| Trialmed San Antonio | San Antonio | Texas | |
| Olympus Clinical Research | Sugar Land | Texas | |
| Medical Center Levitas EOOD | Sofia | Bulgaria | |
| Szpital AidPort | Skórzewo | Poland | |
| Ames Medical Research | Bragadiru | Romania | |
| Colentina Clinical Hospital | Bucharest | Romania | |
| Sana Medical Center | Bucharest | Romania | |
| The Oncology Institute | Cluj-Napoca | Romania |
More AFT Pharmaceuticals, Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07687784 on ClinicalTrials.gov ↗ ← All trials in the USA