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Study of Ferric Derisomaltose for Iron Deficiency Anemia in Children

This study is looking at how well and how safely an intravenous (IV) iron medication called ferric derisomaltose works in children from birth to under 18 years old. These children have iron deficiency anemia (IDA), either because of chronic kidney disease not requiring dialysis (NDD-CKD) or because they haven't responded to or can't tolerate oral iron supplements. All participants will receive ferric derisomaltose, with most getting a 20 mg/kg dose and a smaller group receiving 10 mg/kg. The main goal is to see if participants' hemoglobin (Hb) levels, a measure of red blood cells, increase by a certain amount within 1 to 8 weeks. This study aims to help children who need an effective iron treatment.

Study design
This is an open-label study, meaning everyone knows what treatment is being given. It will include 200 participants and is a combined clinical pharmacology and Phase III study.
What's involved
Participants will receive a single dose of ferric derisomaltose. Blood samples will be taken to measure hemoglobin levels from baseline up to 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for changes in hemoglobin levels from baseline at any time from week 1 to week 8 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05179226

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia

Recruiting
PHASE3Up to 17InterventionalTreatment
Pharmacosmos A/S
~200 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Ferric Derisomaltose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of subjects with a Hb increase of ≥1 g/dL (NDD-CKD) or 2 g/dL (intolerant or unresponsive to oral iron). Measurement by bloodsample.
Measured over From baseline at any time from week 1 to week 8

Conditions

Iron Deficiency, Anaemia in Children

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Iron-Deficiency Anemia

NCT05179226

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Pharmacosmos Investigational Site

    Miami, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Pharmacosmos A/S Clinical and Non-clinical Research
[email protected]
+4559485959
Email the study team

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Eligibility criteria

Inclusion

Subjects \<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 child must sign and date the CAF or provide oral assent, if required according to local requirements
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)
Subjects with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b):
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
TSAT ≤20 % or s-ferritin \<100 ng/mL

Exclusion

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 subjects. In order to avoid pregnancy, female subjects of childbearing potential have to use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) or be abstinent during the whole trial period and 7 days after the last dosing. Childbearing potential refers to all female subjects ≥12 years old or \<12 years old who have started menstruating
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 comply with the trial requirements

What this trial measures

  • Incidence of subjects with a Hb increase of ≥1 g/dL (NDD-CKD) or 2 g/dL (intolerant or unresponsive to oral iron). Measurement by bloodsample.From baseline at any time from week 1 to week 8

    Hb (g/dL), measurement by bloodsample analysis