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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
Study summary
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.
Eligibility
Primary outcome measure(s)
- Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5 — 35 days
Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Memorial Healthcare System | Hollywood | Florida | Not Yet Recruiting |
| Wayne State University | Detroit | Michigan | Active Not Recruiting |
| Children's Mercy Hospital | Kansas City | Missouri | Recruiting |
| The Feinstein Institute Medical Research Organization of Northwell Health, Inc. | Lake Success | New York | Not Yet Recruiting |
| Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) | New York | New York | Active Not Recruiting |
| Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM) | The Bronx | New York | Recruiting |
| Akron Nephrology Associates, Inc. | Akron | Ohio | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
| Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika | Budapest | Hungary | Recruiting |
| University Of Szeged | Szeged | Hungary | Recruiting |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas | Lithuania | Not Yet Recruiting |
| Klaipeda Children's Hospital | Klaipėda | Lithuania | Active Not Recruiting |
| Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital) | Vilnius | Lithuania | Not Yet Recruiting |
| Instituto Mexicano De Trasplantes S.C | Cuernavaca | Mexico | Recruiting |
| JM Research, SC | Cuernavaca | Mexico | Active Not Recruiting |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Mexico | Recruiting |
| Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) | Mexico City | Mexico | Recruiting |
| Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku | Bialystok | Poland | Not Yet Recruiting |
| Specjalistyczne Gabinety Sp. z o.o | Krakow | Poland | Active Not Recruiting |
| University Children Hospital | Krakow | Poland | Not Yet Recruiting |
| Polish Mother's Memorial Hospital Research Institute | Lodz | Poland | Not Yet Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03619850 on ClinicalTrials.gov ↗ ← All trials in Mexico