A Phase 3 interventional study of Ferric Derisomaltose in Iron Deficiency, Anaemia in Children, sponsored by Pharmacosmos A/S. Recruiting at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Pharmacosmos A/S · Phase 3, Interventional, and Treatment
Among 21 studies testing iron isomaltoside 1000 in Iron Deficiencies — 9 open to participants now, 9 under way, 2 of them phase 3. iron isomaltoside 1000 · Iron Deficiencies.
Among the 21 studies testing iron isomaltoside 1000 in Iron Deficiencies, this one is the 7th largest by planned enrollment, is the only one that started in 2022, is one of 8 in phase 3, and was the 13th registered.
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's planned enrollment of 200 is above the median of 99 across 301 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →9 of the 21 studies testing iron isomaltoside 1000 in Iron Deficiencies are open now, in 4 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 55 Iron Deficiencies studies recruiting now, 23 (42%) set no upper age limit and 28 (51%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: Up to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 10 · Phase 4 7
First in 2009; this study’s year is marked. 1 started in 2022.
Median enrollment 170 across the 21 interventional studies. Of the 10 that completed or were terminated, 4 (40%) have results posted.
8 of 21 have an industry lead sponsor. The 10 most frequent:
Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Pharmacosmos A/S has 8 studies filed under Iron Deficiencies — fewer than ten, so there is no comparison to draw.
6 of the studies testing iron isomaltoside 1000 in Iron Deficiencies that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05179226Phase 3Pharmacosmos A/SMulti-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia | 2027-04-30 |
| NCT06287619University Health Network, TorontoPost-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery | 2026-12 |
| NCT07236788China-Japan Friendship HospitalStudy on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency. | 2026-12-30 |
| NCT05971732China-Japan Friendship HospitalThe Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF) | 2027-08-01 |
| NCT05991128China-Japan Friendship HospitalThe Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life | 2027-08-01 |
Among the 21 studies testing iron isomaltoside 1000 in Iron Deficiencies, from their registry updates:
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.
This is a combined clinical pharmacology and phase III study. The study is a prospective, open-label, multi-center study. Children 0 to \<18 years of age with iron deficiency anemia (IDA) with a) non-dialysis dependent chronic kidney disease (NDD-CKD) or b) who are intolerant or unresponsive to oral iron will be enrolled. The subjects will receive ferric derisomaltose/iron isomaltoside 1000 (Monoferric®) at single doses of 10 mg/kg or 20 mg/kg with a maximal dose of 1000 mg.
A total of 200 subjects will be enrolled. Of these will 24 be part of the PK assessment. PK-subjects will be included in cohorts of 4 with the oldest age group as the first and with ferric derisomaltose 10 mg/kg to be increased to 20 mg/kg for the next cohort. Thus 12 subjects will be treated with 10mg/kg and the remaining 188 subjects with 20mg/kg.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b):
a) Subjects with NDD-CKD:
If on ESA, receiving stable ESA regimen defined as dose adjustments no more than
± 20 % for ≥8 weeks prior to screening
b) Subjects with documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to trial enrolment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects (a total of 200) will be treated with Ferric Derisomaltose. 12 subjects (half of the 24 subjects participating in the PK-part of the trial) will be treated with 10mg/kg while the remaining subjects will be treated with 20 mg/kg. .
Drug: Ferric Derisomaltose
All subjects will be treated with Ferric derisomaltose 20 mg/kg at baseline visit except for 12 subjects included in the PK-group, who will be treated with 10 mg/kg
Also known as: Monofer®, Monoferric®
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.
Hb (g/dL), measurement by bloodsample analysis
Time frame: From baseline at any time from week 1 to week 8
Time to increase Hb ≥1 g/dL (NDD-CKD) or 2 g/dL (intolerant or unresponsive to oral iron). Measurement by bloodsample.
Hb (g/dL), measurement by bloodsample analysis
Time frame: From baseline at any time from week 1 to week 8
Incidence of subjects who achieve a serum (s-) ferritin of ≥100 ng/mL. Measurement by bloodsample.
s-ferritin (ng/mL), measurement by bloodsample analysis
Time frame: At weeks 1, 2, 4, and 8
Incidence of subjects who achieve a TSAT of ≥35 % (NDD-CKD) or ≥20 % (intolerant or unresponsive to oral iron). Measurement by bloodsample.
TSAT (%), measurement by bloodsample analysis
Time frame: At weeks 1, 2, 4, and 8
Total iron PK parameters: AUC0-∞
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: AUC0-t
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: Cmax
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: Tmax
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: Ke
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: T½
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: CL
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Total iron PK parameters: Vd
Total iron (µg/dL), measurement by bloodsample analysis
Time frame: From baseline to day 7
Type and incidence of AEs
Any AE
Time frame: From baseline to week 8
Serious or severe hypersensitivity reaction
Any serious or severe hypersensitivity reaction
Time frame: From treatment (Baseline) to 24 hours
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Apr 2027, 53 months after the start.
Of 16 phase 3 interventional studies under Iron Deficiencies, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 60. This study's planned 53 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Iron isomaltoside 1000