Anemia, Iron DeficiencyPhase 3NCT05304442
IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
A Phase 3 study testing Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric] and Ferrous Sulfate 65 mg elemental iron (325 mg tablets) in people with Anemia, Iron Deficiency and Uterine Bleeding, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anemia, Iron Deficiency, Uterine Bleeding
- What is being tested?
- Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric] and Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to Apr 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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;
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ben Taub Hospital
Houston, Texas, 77030
Stephen Boone, MD, stephen.boone@bcm.edu
About this study
Official title: Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial
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.
Read the detailed description
Iron deficiency anemia (IDA) is the most common hematologic disorder in the United States and worldwide. Patients with moderate to severe anemia often present to the acute care setting for initial assessment and evaluation; women with abnormal uterine bleeding are among those at highest risk. Guidelines on management of this common condition in the emergency department (ED) are lacking.
Although IDA is commonly encountered in the ED, there is a paucity of literature addressing optimal management in this setting. Intravenous (IV) iron therapy is infrequently used in the ED despite evidence of safety and superiority to oral iron therapy in other acute care settings. Furthermore, red blood cell (RBC) transfusions may be over-utilized in hemodynamically stable patients with IDA, potentially increasing risk for transfusion reactions, infection, and allo-antibody formation among other adverse outcomes. Improved treatment of iron deficiency may reduce the need for subsequent RBC transfusions. Compared with oral iron, treatment with intravenous iron may result in improved adherence, fewer health care visits, more rapid correction of IDA, and overall improvement in quality of life.
Historically, older formulations of IV Iron, namely high-molecular weight iron dextran (HMWID), were associated with unacceptably high rates of severe allergic reactions and/or required multiple doses to replete iron stores. However, newer formulations of IV iron are not only extremely safe, but can also be administered as a single "total dose infusion" over a very short time period. These newer forms of IV iron include ferric carboxymaltose, low-molecular weight iron dextran, ferumoxytol, and ferric derisomaltose. When excluding HMWID, a meta-analysis of 97 RCTs found that there was no increase in the risk of serious adverse events (SAE's) with IV iron compared with control and no increased risk of systemic infection.
A large retrospective, "before and after" study conducted in an Italian Emergency Department demonstrated that implementation of Patient Blood Management protocols, including the use of IV iron in the emergency department, resulted in a substantial reduction in red blood cell transfusions, hospitalization, re-transfusion, length of stay and costs. Similar conclusions were reached in smaller studies by Motta et al and Khadadah et al.
The investigators recently published a retrospective cohort study examining current emergency department practices in the evaluation and management of IDA in the target population for the proposed trial. The results of this cohort study revealed that women with AUB and severe anemia are frequently seen in the Ben Taub Emergency Department, that red blood cell transfusions are commonly administered, and that IV iron is infrequently (or never) used in the ED setting. Furthermore, unplanned return visits and recurrent transfusions were common.
- Conditions
- Anemia, Iron Deficiency, Uterine Bleeding
- Being tested
- Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric], Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
- Keywords
- IV Iron, Emergency Department, Iron Deficiency Anemia, Uterine Bleeding
- Medical subject headings
- Anemia, Iron-Deficiency, Uterine Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]Drug
Single Dose of IV Iron
Ferrous Sulfate 65 mg elemental iron (325 mg tablets)Drug
Once daily by mouth for 42 days
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ferric Derisomaltose | Experimental | One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes. Receives: Drug: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric] |
| Oral Iron | Active comparator | ferrous sulfate 65 mg once daily for 42 days. Receives: Drug: Ferrous Sulfate 65 mg elemental iron (325 mg tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in hemoglobin concentration
participants will have increased hemoglobin concentrations
Measured: 3 weeks
Secondary outcomes (1)
mean change in hemoglobin concentration
participants will have increased hemoglobin concentrations
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Sep 2022
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos Therapeutics, Inc.
- Responsible party
- Principal investigator, Stephen Boone MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304442
- Sponsor's protocol ID
- H-49444
- Status last verified
- Dec 2024
- First submitted
- 22 Mar 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31197861Sultan 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.
PubMed 30578747Quintana-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.
PubMed 26674819Beverina 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.
PubMed 31855149Motta 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.
PubMed 31707563Khadadah 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.
PubMed 29664169Boone 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.
PubMed 32593579Achebe 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.
PubMed 32479668
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05304442
- Acronym / sponsor ID
- H-49444
- Conditions
- Anemia, Iron Deficiency, Uterine Bleeding
- Keywords
- IV Iron, Emergency Department, Iron Deficiency Anemia, Uterine Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Pharmacosmos Therapeutics, Inc.
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Iron deficiency anemia (IDA) is the most common hematologic disorder in the United States and worldwide. Patients with moderate to severe anemia often present to the acute care setting for initial assessment and evaluation; women with abnormal uterine bleeding are among those at highest risk. Guidelines on management of this common condition in the emergency department (ED) are lacking.
Although IDA is commonly encountered in the ED, there is a paucity of literature addressing optimal management in this setting. Intravenous (IV) iron therapy is infrequently used in the ED despite evidence of safety and superiority to oral iron therapy in other acute care settings. Furthermore, red blood cell (RBC) transfusions may be over-utilized in hemodynamically stable patients with IDA, potentially increasing risk for transfusion reactions, infection, and allo-antibody formation among other adverse outcomes. Improved treatment of iron deficiency may reduce the need for subsequent RBC transfusions. Compared with oral iron, treatment with intravenous iron may result in improved adherence, fewer health care visits, more rapid correction of IDA, and overall improvement in quality of life.
Historically, older formulations of IV Iron, namely high-molecular weight iron dextran (HMWID), were associated with unacceptably high rates of severe allergic reactions and/or required multiple doses to replete iron stores. However, newer formulations of IV iron are not only extremely safe, but can also be administered as a single "total dose infusion" over a very short time period. These newer forms of IV iron include ferric carboxymaltose, low-molecular weight iron dextran, ferumoxytol, and ferric derisomaltose. When excluding HMWID, a meta-analysis of 97 RCTs found that there was no increase in the risk of serious adverse events (SAE's) with IV iron compared with control and no increased risk of systemic infection.
A large retrospective, "before and after" study conducted in an Italian Emergency Department demonstrated that implementation of Patient Blood Management protocols, including the use of IV iron in the emergency department, resulted in a substantial reduction in red blood cell transfusions, hospitalization, re-transfusion, length of stay and costs. Similar conclusions were reached in smaller studies by Motta et al and Khadadah et al.
The investigators recently published a retrospective cohort study examining current emergency department practices in the evaluation and management of IDA in the target population for the proposed trial. The results of this cohort study revealed that women with AUB and severe anemia are frequently seen in the Ben Taub Emergency Department, that red blood cell transfusions are commonly administered, and that IV iron is infrequently (or never) used in the ED setting. Furthermore, unplanned return visits and recurrent transfusions were common.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ferric Derisomaltose | Experimental | Drug: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes. |
| Oral Iron | Active comparator | Drug: Ferrous Sulfate 65 mg elemental iron (325 mg tablets)ferrous sulfate 65 mg once daily for 42 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]Single Dose of IV Iron | Drug | Intravenous Ferric Derisomaltose |
| Ferrous Sulfate 65 mg elemental iron (325 mg tablets)Once daily by mouth for 42 days | Drug | Oral Iron |
Primary outcome
mean change in hemoglobin concentration
Time frame: 3 weeks
participants will have increased hemoglobin concentrations
1 secondary outcome
mean change in hemoglobin concentration
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 31197861Ferrer-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.
- Background: PubMed 30578747Sultan 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.
- Background: PubMed 26674819Quintana-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.
- Background: PubMed 31855149Beverina 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.
- Background: PubMed 31707563Motta 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.
- Background: PubMed 29664169Khadadah 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.
- Background: PubMed 32593579Boone 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.
- Background: PubMed 32479668Achebe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric] and Ferrous Sulfate 65 mg elemental iron (325 mg tablets) in people with Anemia, Iron Deficiency and Uterine Bleeding, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Boone, MD (8324099126, Stephen.Boone@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change in hemoglobin concentration (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304442, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.