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New treatment option for Iron Deficiency, Anaemia in Children
Official title Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
ClinicalTrials.gov ID: NCT05179226
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 iron deficiency, anaemia in children.
Also referred to as Monofer®, Monoferric®.
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
- Several clinical trials have been reported for ferric derisomaltose where it has been shown to be well tolerated and to improve markers of IDA. All clinical trials with ferric derisomaltose have been performed in adults, however, IDA is not specific to the adult population.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- people \<18 years
- Informed consent and child assent, as age-appropriate, obtained before any trial- related activities and willingness to participate. LAR of the...
- IDA caused by different etiologies such as gastrointestinal disease, NDD-CKD, or other conditions leading to IDA
- Hb concentration less than the 5th percentile for age and sex-specific reference range (Appendix B)
- people with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b): a) people with NDD-CKD:
You likely can't join if
- Anemia caused by factors other than IDA according to Investigator's judgment
- S-ferritin \>600 ng/mL
- Hb ≤5.0 g/dL
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
- ALAT and/or ASAT \>2 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)
- Pregnant or nursing female people. In order to avoid pregnancy, female people of childbearing potential have to use adequate contraception (e.g...
See the full eligibility criteria
- people \<18 years
- Informed consent and child assent, as age-appropriate, obtained before any trial- related activities and willingness to participate. LAR of the subject must sign and date the ICF (according to local requirements). The...
- IDA caused by different etiologies such as gastrointestinal disease, NDD-CKD, or other conditions leading to IDA
- Hb concentration less than the 5th percentile for age and sex-specific reference range (Appendix B)
- people with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b): a) people with NDD-CKD:
- TSAT ≤35 % or s-ferritin \<100 ng/mL
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2
- If on ESA, receiving stable ESA regimen defined as dose adjustments no more than ± 20 % for ≥8 weeks prior to screening b) people with documented history of intolerance or unresponsiveness to oral iron therapy for at...
- TSAT ≤20 % or s-ferritin \<100 ng/mL
- Anemia caused by factors other than IDA according to Investigator's judgment
- S-ferritin \>600 ng/mL
- Hb ≤5.0 g/dL
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
- ALAT and/or ASAT \>2 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)
- Pregnant or nursing female people. In order to avoid pregnancy, female people of childbearing potential have to use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method)...
- Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose
- Received an investigational drug within 30 days prior to screening
- Treatment with IV iron within 10 days prior to screening
- Treatment with blood transfusion, radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 30 days prior to screening
- Planned elective surgery (or planned surgery during the trial period) where significant blood loss is expected within the last 30 days prior to screening
- Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)
- Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
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 all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, 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.