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Iron Supplement
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With 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
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 moreSide effects data
From 2018 Phase 3 trial • 122 Patients • NCT0323706525%
Hypophosphatemia
14%
Blood phosphorus decreased
11%
Nausea
9%
Blood parathyroid hormone increased
7%
Headache
5%
Vomiting
5%
Serum ferritin increased
2%
Vitamin D deficiency
2%
Dehydration
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
American Regent, Inc.Lead Sponsor
61 Previous Clinical Trials
19,435 Total Patients Enrolled
Mark Falone, MDStudy DirectorAmerican Regent
5 Previous Clinical Trials
363 Total Patients Enrolled