Evaluating ferumoxytol for treating iron deficiency anemia in children
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
This study is testing if a new iron treatment called ferumoxytol works better than the usual iron sucrose for kids with iron deficiency anemia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | AMAG Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 15 sites (Little Rock, Arkansas and 14 other locations) |
| Trial ID | NCT03893045 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized, open-label study involves pediatric subjects aged 2 to less than 18 years with iron deficiency anemia (IDA). Participants will be randomly assigned to receive either ferumoxytol or iron sucrose, with treatment regimens designed to assess the efficacy and safety of these interventions. The study will monitor hemoglobin levels and adverse events over a period of five weeks following treatment. The aim is to determine the effectiveness of ferumoxytol compared to traditional iron sucrose therapy in this population.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2 to less than 18 years diagnosed with iron deficiency anemia who have not responded well to oral iron therapy.
Not a fit: Patients with chronic kidney disease or those who have a known hypersensitivity to ferumoxytol or iron sucrose may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children suffering from iron deficiency anemia.
How similar studies have performed: Other studies have shown promising results with ferumoxytol in treating iron deficiency anemia, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 14 other locations
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Not_yet_recruiting)
- University of Florida — Gainesville, Florida, United States (Not_yet_recruiting)
- Optimus U Corporation — Miami, Florida, United States (Recruiting)
- Biomedical Research LLC — Miami, Florida, United States (Recruiting)
- Gwinnett Research Institute — Buford, Georgia, United States (Not_yet_recruiting)
- Sun Research Institute — San Antonio, Texas, United States (Recruiting)
- JSC Saules seimos medicinos centras — Kaunas, Lithuania (Not_yet_recruiting)
- Klaipeda Children's Hospital — Klaipėda, Lithuania (Not_yet_recruiting)
- Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos — Vilnius, Lithuania (Not_yet_recruiting)
- Osrodek Badan Klinicznych In Vivo sp. z o.o. — Bydgoszcz, Poland (Not_yet_recruiting)
- Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek — Dębica, Poland (Not_yet_recruiting)
- Pro Familia Altera Sp. z o.o. — Katowice, Poland (Not_yet_recruiting)
- Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland (Not_yet_recruiting)
- Centrum Zdrowia MDM — Warsaw, Poland (Not_yet_recruiting)
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw, Poland (Not_yet_recruiting)
Study contacts
- Study coordinator: Clinical Trial Interest
- Email: CTInterest@covispharma.com
- Phone: 1-877-374 -4177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.