IDA - Iron Deficiency Anemia study: Ferric derisomaltose vs NovaFerrum
Official title Iron Deficiency Anemia (IDA) and the Brain
ClinicalTrials.gov ID: NCT05929729
What this study is testing
What is Ferric derisomaltose?
This is an investigational injectable iron medicine being studied to treat iron deficiency anemia. It is designed to replace missing iron in the body to help make red blood cells.
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 study is testing whether giving iron to women with moderate or severe anemia can improve brain blood flow, brain connections, and thinking skills. It also looks at whether these changes last after treatment.
- Who it's for
- You may be able to join if you are an adult woman with moderate or severe iron deficiency anemia.
- What's involved
- You will give iron medicine at home and have brain scans and thinking tests at the start and after treatment. You will also give blood samples to check iron levels.
- Time commitment
- The study lasts about 6 months, with visits for scans and tests at the beginning and after the iron treatment.
- 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
- 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%
You likely can't join if
- 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.
See the full eligibility criteria
- 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%
- 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
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.