A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
NCT ID: NCT03619850
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
129 participants
INTERVENTIONAL
2018-08-13
2024-08-31
Brief Summary
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To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA
Secondary Objective:
To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
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Detailed Description
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Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period.
Subjects receive the following:
• Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later
OR
• Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ferumoxytol
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.
Iron sucrose
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).
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has IDA defined as: a) hemoglobin \<12.0 g/dL and b) with either transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT\<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin \<12 g/dL
3. Has Chronic Kidney Disease defined as one of the following:
1. on chronic hemodialysis;
2. receiving chronic peritoneal dialysis;
3. estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2;
4. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for \> 3 months.
4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study
Exclusion Criteria
2. History of allergy to intravenous (IV) iron
3. History of multiple drug allergies (\>2)
4. Low systolic blood pressure (Age 1-9 years \<70 + \[age in years x 2\] mmHg, Age 10-17 years \<90 mmHg)
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin level \>600 ng/mL
2 Years
17 Years
ALL
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Memorial Healthcare System
Hollywood, Florida, United States
Wayne State University
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, United States
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States
Akron Nephrology Associates, Inc.
Akron, Ohio, United States
West Virginia University
Morgantown, West Virginia, United States
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
Budapest, , Hungary
University Of Szeged
Szeged, , Hungary
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, , Lithuania
Klaipeda Children's Hospital
Klaipėda, , Lithuania
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
Vilnius, , Lithuania
Instituto Mexicano De Trasplantes S.C
Cuernavaca, , Mexico
JM Research, SC
Cuernavaca, , Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, , Mexico
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City, , Mexico
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
Bialystok, , Poland
Specjalistyczne Gabinety Sp. z o.o
Krakow, , Poland
University Children Hospital
Krakow, , Poland
Polish Mother's Memorial Hospital Research Institute
Lodz, , Poland
Countries
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Central Contacts
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Other Identifiers
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AMAG-FER-CKD-354
Identifier Type: -
Identifier Source: org_study_id
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