Actively Recruiting
Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
Led by Pharmacosmos A/S · Updated on 2026-04-14
200
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. In fact, children are likely to develop IDA due to their rapid growth. The aim in this trial is to evaluate the efficacy and safety of intravenous (IV) ferric derisomaltose in children 0 to \<18 years of age with IDA due to NDD-CKD or with IDA who are intolerant or unresponsive to oral iron . The subjects will receive ferric derisomaltose/iron isomaltoside 1000 (Monoferric®/Monofer®), at single doses of 10 mg/kg or 20 mg/kg with a maximal dose of 1000 mg. 24 subjects will be part of a PK assessment, meaning that more blood samples will be drawn within the first week after treatment. The blood samples will be used for analysis of the amount of total iron in the blood from treatment is given to day 7. For the individual subject, duration of the trial will be approximately 10 weeks (including a 14-day screening period) and each subject will attend 6-9 visits. Subjects who will be included in the PK assessments will attend 8 (subjects age 6 to \<12 years old and 0 to \<6 years old) or 9 (subjects age 12 to \<18 years old) visits, while the other subjects will attend 6 visits.
CONDITIONS
Official Title
Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child younger than 18 years
- Signed informed consent and assent according to age and local rules
- Iron deficiency anemia caused by conditions like gastrointestinal disease, NDD-CKD, or others
- Hemoglobin below the 5th percentile for age and sex
- For children with NDD-CKD: TSAT 35% or less or serum ferritin less than 100 ng/mL and eGFR under 60 mL/min/1.73m2
- If receiving ESA, stable dose with no more than 20% change for at least 8 weeks before screening
- For children intolerant or unresponsive to oral iron: TSAT 20% or less or serum ferritin less than 100 ng/mL
You will not qualify if you...
- Anemia caused by factors other than iron deficiency anemia
- Serum ferritin above 600 ng/mL
- Hemoglobin 5.0 g/dL or less
- Iron overload conditions like hemochromatosis or hemosiderosis
- Liver enzymes (ALAT or ASAT) more than twice the upper normal limit
- Pregnant or nursing females; females of childbearing potential must use contraception or be abstinent during study and 7 days after
- Previous serious allergic reactions to IV iron compounds including ferric derisomaltose
- Use of investigational drugs within 30 days before screening
- IV iron treatment within 10 days before screening
- Recent blood transfusions, radiotherapy, chemotherapy, or drugs suppressing bone marrow within 30 days
- Planned surgery with expected significant blood loss within 30 days before screening
- Active non-viral infections
- Any other medical or psychiatric condition that may affect safety or compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pharmacosmos Investigational Site
Miami, Florida, United States, 33142
Actively Recruiting
Research Team
P
Pharmacosmos A/S Clinical and Non-clinical Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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