NCT03893045 A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
| NCT ID | NCT03893045 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AMAG Pharmaceuticals, Inc. |
| Condition | Iron Deficiency Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2019-09-18 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 75 participants in total. It began in 2019-09-18 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female 2 years to \<18 years of age at time of consent 2. Has IDA defined as: 1. Hemoglobin (Hgb) \<11.0 g/dL AND 2. Any one or more of the following: * Transferrin saturation (TSAT) \<20% * ferritin \<100 ng/mL 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 Exclusion Criteria: 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose 2. History of allergy to intravenous (IV) iron 3. History of ≥2 clinically significant drug allergies 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. 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. Hgb ≤7.0 g/dL 7. Serum ferritin level \>600 ng/mL
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03893045 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Iron Deficiency Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03893045 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 75 participants.
Is NCT03893045 currently recruiting?
Yes, NCT03893045 is actively recruiting participants. Contact the research team at CTInterest@covispharma.com for enrollment information.
Where is the NCT03893045 trial being conducted?
This trial is being conducted at Little Rock, United States, Gainesville, United States, Miami, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT03893045 clinical trial?
NCT03893045 is sponsored by AMAG Pharmaceuticals, Inc.. The trial plans to enroll 75 participants.