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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

Study Summary

This trial is testing an iron supplement given intravenously to infants with iron deficiency anemia to see if it is safe and effective.

Eligible Conditions
  • Iron-Deficiency Anemia

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
6%
Vitamin D deficiency
6%
Blood parathyroid hormone increased
5%
Headache
5%
Nausea
3%
Hypophosphatemia
2%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Iron Isomaltoside/Ferric Derisomaltose
Ferric Carboxymaltose

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
60 Previous Clinical Trials
19,115 Total Patients Enrolled
Mark Falone, MDStudy DirectorAmerican Regent
4 Previous Clinical Trials
363 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a danger in using Ferric carboxymaltose for patients?

"While there is some evidence indicating that Ferric carboxymaltose is safe, it only received a score of 2 because there is no data yet supporting its efficacy."

Answered by AI

Which medical condition does Ferric carboxymaltose usually alleviate?

"Ferric carboxymaltose is most often used to treat iron deficiency. Additionally, it can be given as a prescription for conditions such as oral cavity, breast feeding, anemia."

Answered by AI

Are researchers still looking for participants in this clinical trial?

"The study, which is looking for participants right now, was originally posted on July 21st, 2020. The listing was most recently edited on August 23rd, 2020."

Answered by AI

Are there any other investigations that have used Ferric carboxymaltose?

"There are currently 22 clinical trials underway for Ferric carboxymaltose, 7 of which are in Phase 3. Although a majority of these medical studies originate from Kano and Lagos,399 total locations worldwide are running trials for this medication."

Answered by AI

Is this clinical trial widely available in the United States?

"There are 5 sites where this trial is enrolling patients. The locations of these clinics include Iowa City, New Hyde Park and Columbus. If you enroll in the study, it would be best to choose a location near you to avoid extensive travel."

Answered by AI

How many individuals are currently enrolled in this study?

"In order to successfully run this clinical trial, 18 patients who meet the specific inclusion criteria are required. Out of multiple locations, such as University of Iowa in Iowa City, Iowa and Cohen Children's Medical Center in New Hyde Park, New york, these patients can choose where they want to participate."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
2022. "Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968379.
~0 spots leftby Oct 2024
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