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

NCT05304442 | Recruiting Phase 3 FDA Drug

• 1 other identifier: H-49444
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• mean change in hemoglobin concentration

  participants will have increased hemoglobin concentrations

  3 weeks

Secondary Outcomes (1)

• mean change in hemoglobin concentration

  6 weeks

Other Outcomes (5)

• mean change in ferritin

  3 weeks

• mean change in ferritin

  6 weeks

• median number of transfusions

  6 weeks

Study Arms (2)

Intravenous Ferric Derisomaltose

EXPERIMENTAL

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

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

Oral Iron

ACTIVE COMPARATOR

ferrous sulfate 65 mg once daily for 42 days.

Drug: Ferrous Sulfate 65 mg elemental iron (325 mg tablets)

Interventions

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

Single Dose of IV Iron

Intravenous Ferric Derisomaltose

Ferrous Sulfate 65 mg elemental iron (325 mg tablets) DRUG

Once daily by mouth for 42 days

Oral Iron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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';

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Pharmacosmos Therapeutics, Inc.: collaborator

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (8)

• Ferrer-Barcelo L, Sanchis Artero L, Sempere Garcia-Arguelles J, Canelles Gamir P, P Gisbert J, Ferrer-Arranz LM, Monzo Gallego A, Plana Campos L, Huguet Malaves JM, Lujan Sanchis M, Ruiz Sanchez L, Barcelo Cerda S, Medina Chulia E. Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding. Aliment Pharmacol Ther. 2019 Aug;50(3):258-268. doi: 10.1111/apt.15327. Epub 2019 Jun 14.

  PMID: 31197861 BACKGROUND

• Sultan P, Bampoe S, Shah R, Guo N, Estes J, Stave C, Goodnough LT, Halpern S, Butwick AJ. Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis. Am J Obstet Gynecol. 2019 Jul;221(1):19-29.e3. doi: 10.1016/j.ajog.2018.12.016. Epub 2018 Dec 19.

  PMID: 30578747 BACKGROUND

• Quintana-Diaz M, Fabra-Cadenas S, Gomez-Ramirez S, Martinez-Virto A, Garcia-Erce JA, Munoz M. A fast-track anaemia clinic in the Emergency Department: feasibility and efficacy of intravenous iron administration for treating sub-acute iron deficiency anaemia. Blood Transfus. 2016 Mar;14(2):126-33. doi: 10.2450/2015.0176-15. Epub 2015 Nov 19.

  PMID: 26674819 BACKGROUND

• Beverina I, Razionale G, Ranzini M, Aloni A, Finazzi S, Brando B. Early intravenous iron administration in the Emergency Department reduces red blood cell unit transfusion, hospitalisation, re-transfusion, length of stay and costs. Blood Transfus. 2020 Mar;18(2):106-116. doi: 10.2450/2019.0248-19. Epub 2019 Dec 17.

  PMID: 31855149 BACKGROUND

• Motta I, Mantovan G, Consonni D, Brambilla AM, Materia M, Porzio M, Migone De Amicis M, Montano N, Cappellini MD. Treatment with ferric carboxymaltose in stable patients with severe iron deficiency anemia in the emergency department. Intern Emerg Med. 2020 Jun;15(4):629-634. doi: 10.1007/s11739-019-02223-z. Epub 2019 Nov 9.

  PMID: 31707563 BACKGROUND

• Khadadah F, Callum J, Shelton D, Lin Y. Improving quality of care for patients with iron deficiency anemia presenting to the emergency department. Transfusion. 2018 Aug;58(8):1902-1908. doi: 10.1111/trf.14626. Epub 2018 Apr 17.

  PMID: 29664169 BACKGROUND

• Boone S, Peacock WF, Ordonez E, Powers JM. Management of Nonpregnant Women Presenting to the Emergency Department With Iron Deficiency Anemia Caused by Uterine Blood Loss: A Retrospective Cohort Study. J Emerg Med. 2020 Sep;59(3):348-356. doi: 10.1016/j.jemermed.2020.05.006. Epub 2020 Jun 24.

  PMID: 32593579 BACKGROUND

• Achebe M, DeLoughery TG. Clinical data for intravenous iron - debunking the hype around hypersensitivity. Transfusion. 2020 Jun;60(6):1154-1159. doi: 10.1111/trf.15837. Epub 2020 Jun 1.

  PMID: 32479668 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Uterine Hemorrhage; Emergencies

Interventions

ferric derisomaltose; ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Stephen Boone, MD

CONTACT

8324099126; Stephen.Boone@bcm.edu

Kelly R Keene, BSN

CONTACT

8323682476; kelly.keene@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: September 15, 2022
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)