Taking people in United StatesPhase 3

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Key facts

Who runs it: Baylor College of Medicine
Where: Houston, United StatesSee the site
Trial code: NCT05304442
Status: Recruiting
Phase: Phase 3
People taking part: 40 people, planned
Started: 15 Sept 2022
Planned end: Apr 2025
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]
Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Record updated: 5 December 2024

Who can take part

Age: 18 years to 65 years
Sex: Women only
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 30 criteriaShow less

Who can take part

Sub-acute or chronic uterine blood loss
Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl
Iron deficiency: Serum ferritin less than or equal to 30 ng/mL
Eligible for discharge from the ED following treatment
Patient able to return for planned follow-up visits at 3 and 6 weeks
Patient able to be reached by telephone
Willing and able to provide consent for participation

Who cannot take part

Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit
Parenteral iron within 4 weeks prior to ED visit
Planned elective major surgery during study period
Other current or recent hematologic therapy, as specified
Current or planned use of antithrombotic therapy (antiplatelet agents or anticoagulants) within study period (Non-aspirin NSAIDs are NOT a contraindication)
History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron
History of any anaphylactic allergy
Active rheumatologic disease, or rheumatologist disease requiring treatment, such as rheumatoid arthritis, systemic lupus erythematosus, or mixed connective tissue disease
Acute heart failure or NYHA II-IV chronic heart failure
Inflammatory bowel disease
Cirrhosis or Decompensated liver disease
Current Systemic Infection (e.g. pneumonia, pelvic inflammatory disease, pyelonephritis). *Cystitis or cervicitis is NOT an exclusion
Any other medical or surgical condition that in the opinion of the treating physician may result in patient being unsuitable for trial participation
Known bleeding disorder platelets < 100,000'
Chronic kidney disease, stage III or greater (eGFR < 60)
Patient requiring hospitalization for any reason
Pregnant or nursing
Incarcerated/Prisoner
Weight < 50 kg
Recent receipt of IV iron, erythropoiesis-stimulating agents
Scheduled/planned use of parenteral iron or ESA during study period
Receipt of blood transfusion at index visit
Other significant underlying comorbidity, as specified:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

Where in United States

Ben Taub HospitalHouston, United StatesContact: Stephen Boone, MDTaking people

About the trial

What the trial wants to find out

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

The 2 groups in the trial

Intravenous Ferric DerisomaltoseTreatment being tested
One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.
Treatment: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]
Oral IronExisting treatment, for comparison
ferrous sulfate 65 mg once daily for 42 days.
Treatment: Ferrous Sulfate 65 mg elemental iron (325 mg tablets)