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NCT05179226 · ClinicalTrials.gov registry record · Phase 3
Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
A Phase 3 study of Iron Deficiency, Anaemia in Children, sponsored by Pharmacosmos A/S.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05179226 is a Phase 3 study of Iron Deficiency, Anaemia in Children that is actively recruiting participants, run by Pharmacosmos A/S. The registered enrollment target is 200 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05179226, a Phase 3 study of Iron Deficiency, Anaemia in Children, is actively recruiting participants, sponsored by Pharmacosmos A/S.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Ferric Derisomaltose
Study Locations (1)
Florida
- Pharmacosmos Investigational Site - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05179226
The ClinicalTrials.gov registry entry for NCT05179226 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacosmos A/S, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Iron Deficiency, Anaemia in Children appearing as the primary indexed condition, and to 1 intervention - of which Ferric Derisomaltose is the first listed.
NCT05179226 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05179226 about?
NCT05179226 is a clinical study titled "Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia". 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 lik...
What is the current status of trial NCT05179226?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2022-11-28. Estimated completion is 2026-04-30.
What conditions does trial NCT05179226 study?
This clinical trial studies the following conditions: Iron Deficiency, Anaemia in Children.
What interventions are being tested in trial NCT05179226?
The interventions under investigation include: Ferric Derisomaltose (DRUG).
Who is sponsoring clinical trial NCT05179226?
This trial is sponsored by Pharmacosmos A/S, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05179226 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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