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New treatment option for IDA - Iron Deficiency Anemia
Official title Iron Deficiency Anemia (IDA) and the Brain
ClinicalTrials.gov ID: NCT05929729
What this study is testing
What is Ferric derisomaltose?
Ferric derisomaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ida - iron deficiency anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- Observational arm:
- Age between 16 and 60 years of age.
- Any ethnicity.
- Female
- Anemic group: hemoglobin ≤10.5 g/dl or hematocrit \<32% from finger prick or plethysmography test, or \<11 g/dl from venipuncture blood draw
You likely can't join if
- Observational arm:
- Diabetes requiring medication.
- Hypertension requiring medication.
- Sleep disordered breathing requiring intervention.
- Body mass index \>40 (morbid obesity)
- Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
See the full eligibility criteria
- Observational arm:
- Age between 16 and 60 years of age.
- Any ethnicity.
- Female
- Anemic group: hemoglobin ≤10.5 g/dl or hematocrit \<32% from finger prick or plethysmography test, or \<11 g/dl from venipuncture blood draw
- Control group: hemoglobin \>13.2 g/dl or hematocrit \>39.6%
- treatment arm:
- Criteria for observational component, plus
- Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA, hemoglobin electrophoresis
- Observational arm:
- Diabetes requiring medication.
- Hypertension requiring medication.
- Sleep disordered breathing requiring intervention.
- Body mass index \>40 (morbid obesity)
- Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
- Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
- Known HIV.
- treatment arm:
- Criteria for observational component, plus
- Prior reaction to intravenous iron.
- History of multiple drug allergies.
- History of severe asthma, eczema, or atopy.
- Systemic mastocytosis.
- Severe respiratory or cardiac disease.
- Having no access to a physician who can manage the iron deficiency anemia.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.