Clinical trial
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
Name
AMAG-FER-IDA-352
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).
Trial arms
Trial start
2019-09-18
Estimated PCD
2024-07-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
ferumoxytol
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution
Arms:
Ferumoxytol
Other names:
Feraheme
Iron sucrose
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
Arms:
Iron sucrose
Other names:
Venofer
Size
75
Primary endpoint
Change in Hemoglobin from Baseline to Week 5
35 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2023-07-27
1 organization
2 products
1 indication
Organization
AMAG PharmaceuticalsProduct
ferumoxytolIndication
Iron Deficiency AnemiaProduct
Iron sucrose