NCT05304442 IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
| NCT ID | NCT05304442 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Baylor College of Medicine |
| Condition | Anemia, Iron Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2022-09-15 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patient requiring hospitalization for any reason; * Pregnant or nursing; * Incarcerated/Prisoner; * Weight \< 50 kg; * History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron; * History of any anaphylactic allergy; * Recent receipt of IV iron, erythropoiesis-stimulating agents; * Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit; * Parenteral iron within 4 weeks prior to ED visit; * Scheduled/planned use of parenteral iron or ESA during study period; * Receipt of blood transfusion at index 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); * Known bleeding disorder platelets \< 100,000'; * Other significant underlying comorbidity, as specified: * 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; * Chronic kidney disease, stage III or greater (eGFR \< 60); * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05304442 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Anemia, Iron Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05304442 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT05304442 currently recruiting?
Yes, NCT05304442 is actively recruiting participants. Contact the research team at Stephen.Boone@bcm.edu for enrollment information.
Where is the NCT05304442 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05304442 clinical trial?
NCT05304442 is sponsored by Baylor College of Medicine. The trial plans to enroll 40 participants.