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Iron Supplement

Ferric carboxymaltose for Iron-Deficiency Anemia

Phase 2

Waitlist Available

Research Sponsored by American Regent, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to days 8, 15, 22, and 36

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment where iron is given directly into the bloodstream to help infants with low iron levels. The goal is to see if this method is safe and effective in improving their anemia symptoms. Iron treatments have become safe, effective, and easy to administer in recent years.

Eligible Conditions

Iron-Deficiency Anemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to days 8, 15, 22, and 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to days 8, 15, 22, and 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to days 8, 15, 22, and 36 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in hemoglobin (Hb): g/dL

Change in reticulocytes count: %

Evaluate the PD parameters - Change in serum ferritin: ng/mL

+4 more

Side effects data

From 2018 Phase 3 trial • 122 Patients • NCT03237065

25%

Hypophosphatemia

14%

Blood phosphorus decreased

11%

Nausea

Blood parathyroid hormone increased

Headache

Vomiting

Serum ferritin increased

Vitamin D deficiency

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Ferric Carboxymaltose

Iron Isomaltoside/Ferric Derisomaltose

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: InjectaferExperimental Treatment1 Intervention

To evaluate the safety, tolerance, PK and PD profile of intravenous (IV) FCM in infants 0 to 1 year of age with IDA after receiving a 7.5 mg/kg dose dose of FCM.

Group II: Ferric CarboxymaltoseExperimental Treatment1 Intervention

To evaluate the safety, tolerance, PK and PD profile of intravenous (IV) FCM in infants 0 to 1 year of age with IDA after receiving a 5.0 mg/kg dose of FCM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferric carboxymaltose

FDA approved

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