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)

July 18, 2023 updated by: AMAG Pharmaceuticals, Inc.

A Phase 3, Randomized, Open-Label, Multicenter 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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose.

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).

Study Type

Interventional

Enrollment (Estimated)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
      • Szeged, Hungary
        • Recruiting
        • University of Szeged
  • Lithuania
      • Kaunas, Lithuania
        • Not yet recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
      • Klaipėda, Lithuania
        • Active, not recruiting
        • Klaipeda Children's Hospital
      • Vilnius, Lithuania
        • Not yet recruiting
        • Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
  • Mexico
      • Cuernavaca, Mexico
        • Recruiting
        • Instituto Mexicano De Trasplantes S.C
      • Cuernavaca, Mexico
        • Active, not recruiting
        • JM Research, SC
      • Guadalajara, Mexico
        • Recruiting
        • Hospital Civil De Guadalajara Fray Antonio Alcalde
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
  • Poland
      • Białystok, Poland
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
      • Kraków, Poland
        • Active, not recruiting
        • Specjalistyczne Gabinety Sp. z o.o
      • Kraków, Poland
        • Not yet recruiting
        • University Children hospital
      • Łódź, Poland
        • Not yet recruiting
        • Polish Mother's Memorial Hospital Research Institute
  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
        • Not yet recruiting
        • Memorial Healthcare System
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Active, not recruiting
        • Wayne State University
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
      • Lake Success, New York, United States, 11042
        • Not yet recruiting
        • The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
    • Ohio
      • Akron, Ohio, United States, 44302
        • Recruiting
        • Akron Nephrology Associates, Inc.
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 ≤7.0 g/dL
  6. Serum ferritin level >600 ng/mL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferumoxytol
Drug: 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.
Other Names:
  • Feraheme
Active Comparator: Iron sucrose
Drug: 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 Names:
  • Venofer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Time Frame: 35 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events
Time Frame: 49 days
Incidence of Treatment Emergent Adverse Events
49 days
Incidence of adverse events of special interest (AESI)
Time Frame: 49 days
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
49 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC)
Time Frame: 35 days
Pharmacokinetic parameter: Area Under the Curve (AUC)
35 days
Clearance
Time Frame: 35 days
Pharmacokinetic parameter: clearance
35 days
Distribution and elimination half-lives
Time Frame: 35 days
Pharmacokinetic parameter: distribution and elimination half-lives
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMAG Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2018

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

August 31, 2023

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMAG-FER-CKD-354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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