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)
Recruiting · NCT03619850 · Interventional (participants receive a specific treatment) · Lead sponsor: AMAG Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
FerumoxytolIron sucrose
What this trial is about
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.
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female 2 years to \<18 years of age at time of consent
- 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
- Has Chronic Kidney Disease defined as one of the following:
- on chronic hemodialysis;
- receiving chronic peritoneal dialysis;
- estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2;
- 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.
- 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
- 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
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
- History of allergy to intravenous (IV) iron
- History of multiple drug allergies (\>2)
- Low systolic blood pressure (Age 1-9 years \<70 + \[age in years x 2\] mmHg, Age 10-17 years \<90 mmHg)
- Hemoglobin ≤7.0 g/dL
- Serum ferritin level \>600 ng/mL
Where it is running
21 locations listed across 6 US states.
- 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
- Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku - Bialystok, Poland
- Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika - Budapest, Hungary
- Instituto Mexicano De Trasplantes S.C - Cuernavaca, Mexico
- JM Research, SC - Cuernavaca, Mexico
- Hospital Civil de Guadalajara Fray Antonio Alcalde - Guadalajara, Mexico
- Hospital of Lithuanian University of Health Sciences Kauno klinikos - Kaunas, Lithuania
- Klaipeda Children's Hospital - Klaipėda, Lithuania
- Specjalistyczne Gabinety Sp. z o.o - Krakow, Poland
- University Children Hospital - Krakow, Poland
- Polish Mother's Memorial Hospital Research Institute - Lodz, Poland
- Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) - Mexico City, Mexico
- University Of Szeged - Szeged, Hungary
- Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital) - Vilnius, Lithuania