Recruiting
Phase 3

IV Iron

Sponsor:

Baylor College of Medicine

Code:

NCT05304442

Conditions

Anemia, Iron Deficiency

Uterine Bleeding

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]

Ferrous Sulfate 65 mg elemental iron (325 mg tablets)

Study Details

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.

Conditions

Anemia, Iron Deficiency

Uterine Bleeding

Study ID

NCT05304442

Start date

Sep 15, 2022

Status verified date

Dec, 2024

Completion date

Apr, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intravenous Ferric Derisomaltose

One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.

active comparator: Oral Iron

ferrous sulfate 65 mg once daily for 42 days.

Interventions

Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]

Single Dose of IV Iron

Ferrous Sulfate 65 mg elemental iron (325 mg tablets)

Once daily by mouth for 42 days

Primary outcome measure

  • mean change in hemoglobin concentration [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Stephen Boone, MD

8324099126Stephen.Boone@bcm.edu

Kelly R Keene, BSN

8323682476kelly.keene@bcm.edu

Locations

Ben Taub Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephen Boone, MD

stephen.boone@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Dec 5, 2024

Last verified

Dec, 2024

Keywords

  • IV Iron
  • Emergency Department
  • Iron Deficiency Anemia
  • Uterine Bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2024-12-05.