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Compares treatment options for Iron Deficiency Anaemia in Childbirth
Official title Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
ClinicalTrials.gov ID: NCT05251493
What this study is testing
What is Iron Isomaltoside 1000, ferric derisomaltose?
Iron Isomaltoside 1000, ferric derisomaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for iron deficiency anaemia in childbirth.
Also referred to as Monoferric DIN 22477777.
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
- Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester.
- Phase 3: a large, late-stage study
- 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 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- 18 years of age and over
- Pregnancy with Gestational age ≥13 weeks
- Iron deficiency anemia defined as:
- Hemoglobin less than or equal to 110g/L and
- Serum ferritin less than 30ng/mL or
You likely can't join if
- Pregnancy GA less than 13 weeks
- History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
- Known serious hypersensitivity to other parental iron products
- Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
- Decompensated liver cirrhosis or active hepatitis
- History of multiple allergies
See the full eligibility criteria
- 18 years of age and over
- Pregnancy with Gestational age ≥13 weeks
- Iron deficiency anemia defined as:
- Hemoglobin less than or equal to 110g/L and
- Serum ferritin less than 30ng/mL or
- Iron Saturation (Iron/TIBC) less than 20%
- Willing to participate and attend all planned follow up visits
- Willing to sign informed consent form
- Willing to attend appointments for iron infusion and follow up visits
- Willing to attend all planned bloodwork appointments
- Pregnancy GA less than 13 weeks
- History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
- Known serious hypersensitivity to other parental iron products
- Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
- Decompensated liver cirrhosis or active hepatitis
- History of multiple allergies
- Active acute or chronic infections
- Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
- Current participation in any other treatment trial
- Multiple gestation pregnancy
- Significant comorbidities (asthma requiring daily therapy or other lung diseases)
- Heart disease
- Kidney disease
- Rheumatologic disease
- Cancer
- Known hypersensitivity to iron sucrose or any excipients
- Known hypersensitivity to iron isomaltoside or any excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Regina, Saskatchewan, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Regina, Saskatchewan, Canada. 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.