RECRUITING

A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

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Conditions

Iron Deficiency AnemiaIDAanemiapediatricsferumoxytoliron sucrose

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).

Official Title

A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Quick Facts

Study Start:2019-09-18
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03893045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female 2 years to \<18 years of age at time of consent
  2. 2. Has IDA defined as:
  3. 1. Hemoglobin (Hgb) \<11.0 g/dL AND
  4. 2. Any one or more of the following:
  5. * Transferrin saturation (TSAT) \<20%
  6. * ferritin \<100 ng/mL
  7. 3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
  1. 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
  2. 2. History of allergy to intravenous (IV) iron
  3. 3. History of ≥2 clinically significant drug allergies
  4. 4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
  5. 5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg)
  6. 6. Hgb ≤7.0 g/dL
  7. 7. Serum ferritin level \>600 ng/mL

Contacts and Locations

Study Contact

Clinical Trial Interest
CONTACT
1-877-374 -4177
CTInterest@covispharma.com

Study Locations (Sites)

Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
University of Florida
Gainesville, Florida, 32608
United States
Optimus U Corporation
Miami, Florida, 33125
United States
Biomedical Research LLC
Miami, Florida, 33184
United States
Gwinnett Research Institute
Buford, Georgia, 30519
United States
Sun Research Institute
San Antonio, Texas, 78215
United States

Collaborators and Investigators

Sponsor: AMAG Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-18
Study Completion Date2025-10

Study Record Updates

Study Start Date2019-09-18
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • IDA
  • anemia
  • pediatrics
  • ferumoxytol
  • iron sucrose

Additional Relevant MeSH Terms

  • Iron Deficiency Anemia