Back to resultsA Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Primary Purpose
Iron Deficiency Anemia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ferumoxytol
Iron sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring IDA, anemia, pediatrics, ferumoxytol, iron sucrose
Eligibility Criteria
Inclusion Criteria:
- Male or female 2 years to <18 years of age at time of consent
Has IDA defined as:
- Hemoglobin (Hgb) <11.0 g/dL AND
Any one or more of the following:
- Transferrin saturation (TSAT) <20%
- ferritin <100 ng/mL
- 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:
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
- History of allergy to intravenous (IV) iron
- History of ≥2 clinically significant drug allergies
- Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
- Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg, age 10 to 17 years <90 mmHg)
- Hgb ≤7.0 g/dL
- Serum ferritin level >600 ng/mL
Sites / Locations
- Arkansas Children's Hospital
- University of Florida
- Optimus U CorporationRecruiting
- Biomedical Research LLCRecruiting
- Gwinnett Research Institute
- Sun Research InstituteRecruiting
- JSC Saules seimos medicinos centras
- Klaipeda Children's Hospital
- Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
- Osrodek Badan Klinicznych In Vivo sp. z o.o.
- Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
- Pro Familia Altera Sp. z o.o.
- Korczowski Bartosz, Gabinet Lekarski
- Centrum Zdrowia MDM
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferumoxytol
Iron sucrose
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Change in Hemoglobin from Baseline to Week 5
Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5
Secondary Outcome Measures
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Full Information
NCT ID
NCT03893045
First Posted
March 22, 2019
Last Updated
July 25, 2023
Sponsor
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03893045
Brief Title
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMAG Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Subjects will be randomized to treatment in a 2:1 ratio (ferumoxytol: iron sucrose) and stratified by age group (2 to <6 years; 6 to <12 years; and 12 to <18 years). Subjects will receive one of the following treatment regimens:
• Ferumoxytol: 7 mg Fe/kg IV (maximum 510 mg/dose) x 2 doses, the first dose administered on Day 1 and the second 2 to 8 days later.
OR
• Iron sucrose (Venofer®): 4 mg Fe/kg IV (maximum 200 mg/dose) x 5 doses, the first dose on Day 1 and subsequent doses administered at least once per week and up to 3 times/week. All subjects will be monitored at the study site through at least 1 hour after the completion of each infusion of study drug. Assessment of blood Hgb concentrations, adverse events, and other safety assessments will be performed through study Week 5.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
IDA, anemia, pediatrics, ferumoxytol, iron sucrose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ferumoxytol
Arm Type
Experimental
Arm Description
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.
Arm Title
Iron sucrose
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Other Intervention Name(s)
Venofer
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Hemoglobin from Baseline to Week 5
Description
Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Incidence of Treatment Emergent Adverse Events
Time Frame
49 days
Title
Incidence of adverse events of special interest (AESI)
Description
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Time Frame
49 days
Other Pre-specified Outcome Measures:
Title
Area Under the Curve (AUC)
Description
Pharmacokinetic parameter: Area Under the Curve (AUC)
Time Frame
35 days
Title
Clearance
Description
Pharmacokinetic parameter: Clearance
Time Frame
35 days
Title
Distribution
Description
Pharmacokinetic parameter: Distribution
Time Frame
35 days
Title
Elimination half-lives
Description
Pharmacokinetic parameter: Elimination half-lives
Time Frame
35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 2 years to <18 years of age at time of consent
Has IDA defined as:
Hemoglobin (Hgb) <11.0 g/dL AND
Any one or more of the following:
Transferrin saturation (TSAT) <20%
ferritin <100 ng/mL
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:
Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
History of allergy to intravenous (IV) iron
History of ≥2 clinically significant drug allergies
Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg, age 10 to 17 years <90 mmHg)
Hgb ≤7.0 g/dL
Serum ferritin level >600 ng/mL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Interest
Phone
1-877-374 -4177
Email
CTInterest@covispharma.com
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Biomedical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Individual Site Status
Recruiting
Facility Name
Gwinnett Research Institute
City
Buford
State/Province
Georgia
ZIP/Postal Code
30519
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
JSC Saules seimos medicinos centras
City
Kaunas
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Klaipeda Children's Hospital
City
Klaipėda
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Osrodek Badan Klinicznych In Vivo sp. z o.o.
City
Bydgoszcz
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
City
Debica
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Pro Familia Altera Sp. z o.o.
City
Katowice
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszów
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Zdrowia MDM
City
Warsaw
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wrocław
Country
Poland
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
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