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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

Must not have

Pregnant or nursing female subjects

Treatment with blood transfusion, radiotherapy, chemotherapy or other drugs that suppress the bone marrow within 30 days prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at weeks 1, 2, 4, and 8

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or nursing.

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I haven't had treatments like blood transfusions or chemotherapy in the last 30 days.

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I have a non-viral infection.

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I have issues with iron overload or using iron properly.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 1, 2, 4, and 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

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.

Trial 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. .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferric Derisomaltose

2021

Completed Phase 4

~1270

0 / 7Eligibility criteria met