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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Pharmacosmos Therapeutics, Inc.

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