120 Participants Needed

Iron Replacement Therapy for Iron-Deficiency Anemia

(IDA Trial)

Recruiting at 3 trial locations
SS
Overseen BySilvie Suriany, MSc
Age: < 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Children's Hospital Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people who need medication for diabetes or hypertension. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Ferric carboxymaltose for treating iron-deficiency anemia?

Ferric carboxymaltose is effective in treating iron-deficiency anemia, as it replenishes iron stores and corrects anemia in various populations, including those with chronic kidney disease, inflammatory bowel disease, and postpartum anemia. It is generally well tolerated and may require fewer doses compared to other iron treatments, with a lower incidence of gastrointestinal side effects.12345

Is iron replacement therapy safe for humans?

Iron replacement therapy, such as ferric carboxymaltose and ferrous sulfate, is generally safe for humans. However, some people may experience mild side effects like nausea or low phosphate levels in the blood, which are usually temporary and not serious. Ferric carboxymaltose is often better tolerated than oral ferrous sulfate, with fewer stomach-related side effects.12678

What makes ferric carboxymaltose unique for treating iron-deficiency anemia?

Ferric carboxymaltose is unique because it is administered intravenously, allowing for a high dose of iron to be delivered quickly, often in just 15 minutes, which means fewer doses are needed compared to other treatments. It is generally better tolerated than oral iron supplements like ferrous sulfate, with fewer gastrointestinal side effects.12356

What is the purpose of this trial?

This is a trial with an observational and an interventional arm, in patients with moderate to severe anemia and control subjects. The main purposes of this study is to phenotype the scope of neurocognitive deficits from iron deficiency anemia (IDA) in adult women, determine derangements in cerebral perfusion, vascular reactivity, functional connectivity, and blood brain barrier permeability in adult-onset IDA and relate them to neurocognitive deficits, as well as determine the reversibility and durability of both the physiologic and neurocognitive derangements by iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.

Research Team

JW

John Wood, MD,PhD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for adult women aged 18-60 with moderate to severe iron deficiency anemia (IDA). Participants must have specific lab results indicating IDA and a hemoglobin level ≤10.5 g/dl or hematocrit <32%. Exclusions include MRI contraindications, systemic inflammatory diseases, severe asthma, eczema, atopy, diabetes on medication, hypertension on medication, prior reaction to IV iron, severe respiratory/cardiac disease or morbid obesity.

Inclusion Criteria

In the observational group, the control group should have hemoglobin levels above 13.2 g/dl or hematocrit levels above 39.6%.
My blood tests show I have low hemoglobin or hematocrit levels.
I have iron deficiency anemia as diagnosed by a hematologist.
See 2 more

Exclusion Criteria

I had a reaction to intravenous iron in the past.
I am taking medication for high blood pressure.
I have severe heart or lung disease.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Comprehensive cerebrovascular MRI, bloodwork, patient-reported outcomes, and neurocognitive testing are collected from all subjects in the observational arm.

Baseline (Day 0)
1 visit (in-person)

Intervention

Eligible anemic subjects receive either intravenous iron therapy or standard oral iron therapy. Repeated tests are conducted to assess the effects and durability of iron therapy.

12 months
Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at various time points including Day 14, Day 90, Day 180, and Day 365 post iron therapy.

12 months
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • Ferric carboxymaltose
  • Ferrous sulfate
Trial Overview The study aims to understand the impact of IDA on brain function and structure in women and test if these effects can be reversed by iron replacement therapy. It involves two treatments: NovaFerrum and Ferric derisomaltose. The trial has both observational (examining existing conditions) and interventional (testing new treatments) components.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous (IV) ironExperimental Treatment2 Interventions
This group will receive intravenous iron (Ferric Derisomaltose) in a single dose of 20 mg/kg (max individual dose of 1000 mg). The drug is administered as an infusion over 30 minutes. 3 months after the infusion, they will receive a 9-month supply of Novaferrum pill to be taken once a day.
Group II: Standard of care ironActive Control1 Intervention
This group will be referred to their primary care provider for oral iron therapy. If a participant cannot obtain care from a physician
Group III: Healthy ControlsActive Control1 Intervention
This group will only be participating in the observational part of the study and serve as our controls.

Ferric carboxymaltose is already approved in European Union, Canada, United States for the following indications:

🇪🇺
Approved in European Union as Ferinject for:
  • Iron deficiency anemia in adult and pediatric patients when oral iron preparations are not tolerated or are ineffective
🇨🇦
Approved in Canada as Ferinject for:
  • Iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective
  • Iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity
🇺🇸
Approved in United States as Ferinject for:
  • Iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Findings from Research

Ferric carboxymaltose is an effective intravenous treatment for iron-deficiency anemia, rapidly improving hemoglobin levels and replenishing iron stores in various patient populations, including those with chronic kidney disease and inflammatory bowel disease, with a single dose of up to 1000 mg administered in 15 minutes.
The treatment is well tolerated, with mild to moderate side effects similar to those of oral iron supplements, and it shows a faster improvement in hemoglobin levels compared to ferrous sulfate, making it a preferred option for patients who cannot take oral iron.
Ferric carboxymaltose: a review of its use in iron-deficiency anaemia.Lyseng-Williamson, KA., Keating, GM.[2022]
Ferric carboxymaltose is an effective intravenous iron treatment for iron deficiency, allowing for a single high dose infusion (up to 1000 mg) that can improve patient outcomes in conditions like chronic heart failure, as shown in two randomized trials (FAIR-HF and CONFIRM-HF).
It is generally well tolerated with a low risk of hypersensitivity reactions and fewer gastrointestinal side effects compared to oral iron supplements, making it a preferable option for replenishing iron stores in various populations.
Ferric carboxymaltose: a review of its use in iron deficiency.Keating, GM.[2022]
Iron carboxymaltose is as effective as ferrous sulfate for treating postpartum iron deficiency anemia, achieving similar increases in hemoglobin levels in just 2 weeks compared to 12 weeks for ferrous sulfate.
Iron carboxymaltose is better tolerated than ferrous sulfate, with fewer gastrointestinal side effects and no safety concerns for breast-fed infants, making it a safer and more convenient treatment option.
Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia.Breymann, C., Gliga, F., Bejenariu, C., et al.[2022]

References

Ferric carboxymaltose: a review of its use in iron-deficiency anaemia. [2022]
Ferric carboxymaltose: a review of its use in iron deficiency. [2022]
Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. [2022]
A comparative trial of a controlled-release iron tablet preparation ('Ferrocontin' Continus) and ferrous fumarate tablets. [2016]
[Efficacy and tolerability of ferric carboxymaltose in geriatric patients with anemia. Data from three non-interventional studies]. [2022]
Hypophosphatemic osteomalacia, a side effect of iron carboxymaltose administration. [2022]
Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. [2022]
Adverse effects of iron supplementation: a comparative trial of a wax-matrix iron preparation and conventional ferrous sulfate tablets. [2014]
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