Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

Withdrawn before enrolling · Phase 2

Conditions studied: Iron Deficiency, Anaemia

In brief

An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 year) with Iron Deficiency Anemia.

Key facts

Study ID

NCT04968379

Run by

American Regent, Inc.

People needed

0

Starts

2022-07-21

Expected to finish

2024-12-12

Last updated by the study team

2023-01-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants 0 to 1 year of age, medically indicated for iron replacement, with his/her parent or legal guardian willing and able to sign the informed consent form approved by the IRB / Independent Ethics Committee (IEC).
• Screening Hb ≥7 g/dL to <10 g/dL.
• Infants with any of the following conditions:
• Heart failure with IDA defined as syndromes of excessive preload, excessive afterload, abnormal rhythm, or decreased contractility
• Gastrointestinal diseases with acquired short bowel syndrome (due to volvulus, necrotizing enterocolitis from surgical resection or spontaneous intestinal perforation)
• Gastrointestinal intolerance of oral iron or an unsatisfactory response to oral iron
• Other conditions associated with IDA which in the opinion of the investigator might benefit from administration of FCM

You may not qualify if…

• Known history of hypersensitivity reaction to FCM.
• Body weight <2.5 kg.
• History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.
• Hemodialysis-dependent chronic kidney disease.
• History of significant diseases of the liver, hematopoietic system, cardiovascular system, or other conditions which, on the opinion of the investigator, may place a participant at added risk for participation in the study.
• Active infection.
• Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy vitamin B12 deficiency, or folic acid deficiency).
• Blood transfusion in the 4 weeks prior to consent.
• Administration of an iron-containing product within 14 days of administration of the study article.
• Administration and / or use of an investigational product (drug or device) within 30 days of screening.
• Current participation in another clinical trial.
• Unable to comply with study procedures and assessments.

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Cohen Children's Medical Center — New Hyde Park, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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