← Back to Search

Iron Supplement

Iron Replacement Therapy for Iron-Deficiency Anemia (IDA Trial)

Phase 4

Recruiting

Led By John Wood, MD, PhD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Observational arm: Anemic group: hemoglobin ≤10.5 g/dl or hematocrit <32% from finger prick or plethysmography test, or <11 g/dl from venipuncture blood draw

Observational arm: Female

Must not have

Interventional arm: Criteria for observational component, plus Prior reaction to intravenous iron

Observational arm: Hypertension requiring medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14 (for iv iron group only), day 90, day 180, day 365

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies the effects of iron deficiency anemia on adult women's cognition, brain blood flow, and brain function, and the reversibility of effects with iron replacement therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the interventions may include allergic reactions like itching or rash; gastrointestinal issues such as nausea or constipation; headaches; dizziness; muscle cramps; infusion-related reactions including low blood pressure or fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood tests show I have low hemoglobin or hematocrit levels.

Select...

I am a woman.

Select...

I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had a reaction to intravenous iron in the past.

Select...

I am taking medication for high blood pressure.

Select...

I have severe heart or lung disease.

Select...

I need treatment for my sleep-related breathing problem.

Select...

My BMI is over 40, indicating morbid obesity.

Select...

I have a known inflammatory disease like IBD, lupus, or scleroderma.

Select...

I have been diagnosed with systemic mastocytosis.

Select...

I have diabetes and take medication for it.

Select...

I don't have a doctor to treat my iron deficiency anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14 (for iv iron group only), day 90, day 180, day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14 (for iv iron group only), day 90, day 180, day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 (for iv iron group only), day 90, day 180, day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Impact of iron deficiency anemia on blood brain barrier permeability surface area product (ml H20/100g/min)

Impact of iron deficiency anemia on cerebral metabolic rate of oxygen (ml O2/100g/min).

Impact of iron deficiency anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)

+34 more

Secondary study objectives

Acute impact of intravenous (IV) iron therapy on list learning and recall task in people with iron deficiency anemia.

Acute impact of intravenous (IV) iron therapy on visuospatial memory in people with iron deficiency anemia.

Changes in Restless Legs Syndrome (RLS) as an effect of iron therapy in people with iron deficiency anemia will be assessed post iron therapy.

+8 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 12Eligibility criteria met