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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)

RecruitingPhase 3Ages 2 Years - 17 YearsAllAMAG Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

Primary Objectives: 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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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female 2 years to \<18 years of age at time of consent 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: 1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose 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 โ‰ค7.0 g/dL 6. Serum ferritin level \>600 ng/mL
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What it tests

  • Ferumoxytol
  • Iron sucrose
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Where

21 sites
Memorial Healthcare System
Hollywood, United States
Wayne State University
Detroit, United States
Children's Mercy Hospital
Kansas City, United States
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, United States
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, United States
Akron Nephrology Associates, Inc.
Akron, United States
West Virginia University
Morgantown, United States

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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