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)

NCT03619850 | Recruiting Phase 3 FDA Drug

• 1 other identifier: AMAG-FER-CKD-354
• Study Type: interventional
• Target: 129
• Locations: 5 countries
• Sites: 21

Brief 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.

Conditions

Chronic Kidney Disease; Iron Deficiency Anemia

Keywords

Iron deficiency anemia (IDA); chronic kidney disease (CKD); pediatrics; ferumoxytol; iron sucrose; Feraheme; Venofer

Outcome Measures

Primary Outcomes (1)

• Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5

  Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5

  35 days

Secondary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events

  49 days

• Incidence of adverse events of special interest (AESI)

  49 days

Other Outcomes (3)

• Area Under the Curve (AUC)

  35 days

• Clearance

  35 days

• Distribution and elimination half-lives

  35 days

Study Arms (2)

Ferumoxytol

EXPERIMENTAL

Drug: Ferumoxytol

Iron sucrose

ACTIVE COMPARATOR

Drug: Iron sucrose

Interventions

Ferumoxytol DRUG

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.

Also known as: Feraheme

Ferumoxytol

Iron sucrose DRUG

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).

Also known as: Venofer

Iron sucrose

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (21)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

Wayne State University

Detroit, Michigan, 48201, United States

ACTIVE NOT RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

The Feinstein Institute Medical Research Organization of Northwell Health, Inc.

Lake Success, New York, 11042, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)

The Bronx, New York, 10467, United States

RECRUITING

Akron Nephrology Associates, Inc.

Akron, Ohio, 44302, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Clinical Trial Interest

CONTACT

1-877-374 -4177; CTInterest@covispharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 13, 2018
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); US (8); HU (2); LI (3); ME (4)