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Iron Supplement
Ferric Derisomaltose for Iron Deficiency Anemia in Children
Phase 3
Recruiting
Research Sponsored by Pharmacosmos A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to trial enrolment: TSAT ≤20 % or s-ferritin <100 ng/mL
Hb concentration less than the 5th percentile for age and sex-specific reference range
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 1, 2, 4, and 8
Awards & highlights
Study Summary
This trialwill evaluate if ferric derisomaltose is safe and effective for treating iron deficiency anemia in children.
Who is the study for?
This trial is for children under 18 with Iron Deficiency Anemia (IDA) who haven't responded to or can't tolerate oral iron. It includes those with non-dialysis-dependent chronic kidney disease (NDD-CKD), provided they have specific blood test results and are not on certain treatments like IV iron, blood transfusions, or chemotherapy recently.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Ferric Derisomaltose, an intravenous iron treatment for IDA in kids. Participants will receive a single dose based on weight, up to a maximum of 1000 mg. Some will have additional blood tests to measure how much iron stays in their system over a week.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, allergic reactions similar to previous IV iron treatments if any, changes in liver enzymes levels, and possibly other side effects that are common with intravenous iron therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a history of not responding well to oral iron treatments.
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My hemoglobin levels are lower than usual for my age and sex.
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I have kidney disease, low iron levels, and am on a stable anemia treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at weeks 1, 2, 4, and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 1, 2, 4, and 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome 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.
Secondary outcome measures
Incidence of subjects who achieve a TSAT of ≥35 % (NDD-CKD) or ≥20 % (intolerant or unresponsive to oral iron). Measurement by bloodsample.
Incidence of subjects who achieve a serum (s-) ferritin of ≥100 ng/mL. Measurement by bloodsample.
Serious or severe hypersensitivity reaction
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ferric DerisomaltoseExperimental Treatment1 Intervention
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.
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Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferric Derisomaltose
2021
Completed Phase 4
~1270
Find a Location
Who is running the clinical trial?
Pharmacosmos A/SLead Sponsor
44 Previous Clinical Trials
9,502 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant or nursing.Your hemoglobin level is less than 5.0 grams per deciliter.You had a bad allergic reaction to IV iron treatments in the past.I am under 18 and have both my consent and child assent for trial participation.I have iron deficiency anemia due to conditions like stomach issues or kidney disease.I have a history of not responding well to oral iron treatments.You have anemia not caused by iron deficiency, as determined by the doctor.I haven't had treatments like blood transfusions or chemotherapy in the last 30 days.I have a non-viral infection.I have not had any planned surgeries in the last 30 days.My hemoglobin levels are lower than usual for my age and sex.You have any other health issues or mental disorders that could make it hard for you to manage your disease or follow the trial rules.I have issues with iron overload or using iron properly.Your ALAT and/or ASAT levels are more than double the normal limit.I have received IV iron within the last 10 days.I have kidney disease, low iron levels, and am on a stable anemia treatment.Your blood ferritin level is higher than 600 ng/mL.
Research Study Groups:
This trial has the following groups:- Group 1: Ferric Derisomaltose
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what clinical applications is Ferric Derisomaltose frequently employed?
"Ferric Derisomaltose is usually prescribed for iron deficiency, however it can also assist in managing hematochezia, chronic kidney diseases and gastrectomy-related conditions."
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