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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893045
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

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).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: ferumoxytol Drug: Iron sucrose Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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.
Drug: 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
Other Name: Feraheme

Active Comparator: 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)
Drug: 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).
Other Name: Venofer




Primary Outcome Measures :
  1. Change in Hemoglobin from Baseline to Week 5 [ Time Frame: 35 days ]
    Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5


Secondary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: 49 days ]
    Incidence of Treatment Emergent Adverse Events

  2. Incidence of adverse events of special interest (AESI) [ Time Frame: 49 days ]
    Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)


Other Outcome Measures:
  1. Area Under the Curve (AUC) [ Time Frame: 35 days ]
    Pharmacokinetic parameter: Area Under the Curve (AUC)

  2. Clearance [ Time Frame: 35 days ]
    Pharmacokinetic parameter: Clearance

  3. Distribution [ Time Frame: 35 days ]
    Pharmacokinetic parameter: Distribution

  4. Elimination half-lives [ Time Frame: 35 days ]
    Pharmacokinetic parameter: Elimination half-lives



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893045


Contacts
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Contact: Clinical Trial Interest 1-877-233-4781 AMAGCT@druginfo.com

Locations
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United States, Arkansas
Arkansas Children's Hospital Not yet recruiting
Little Rock, Arkansas, United States, 72202
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32608
Optimus U Corporation Recruiting
Miami, Florida, United States, 33125
Biomedical Research LLC Recruiting
Miami, Florida, United States, 33184
United States, Georgia
Gwinnett Research Institute Not yet recruiting
Buford, Georgia, United States, 30519
United States, Texas
Sun Research Institute Recruiting
San Antonio, Texas, United States, 78215
Lithuania
JSC Saules seimos medicinos centras Not yet recruiting
Kaunas, Lithuania
Klaipeda Children's Hospital Not yet recruiting
Klaipėda, Lithuania
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos Not yet recruiting
Vilnius, Lithuania
Poland
Osrodek Badan Klinicznych In Vivo sp. z o.o. Not yet recruiting
Bydgoszcz, Poland
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek Not yet recruiting
Debica, Poland
Pro Familia Altera Sp. z o.o. Not yet recruiting
Katowice, Poland
Korczowski Bartosz, Gabinet Lekarski Not yet recruiting
Rzeszów, Poland
Centrum Zdrowia MDM Not yet recruiting
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Not yet recruiting
Wrocław, Poland
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03893045    
Other Study ID Numbers: AMAG-FER-IDA-352
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AMAG Pharmaceuticals, Inc.:
IDA
anemia
pediatrics
ferumoxytol
iron sucrose
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Ferrosoferric Oxide
Ferric Oxide, Saccharated
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions