Back to resultsA 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 Purpose
Chronic Kidney Disease; Iron Deficiency Anemia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferumoxytol
Iron sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease; Iron Deficiency Anemia focused on measuring Iron deficiency anemia (IDA), chronic kidney disease (CKD), pediatrics, ferumoxytol, iron sucrose, Feraheme, Venofer
Eligibility Criteria
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
Sites / Locations
- Memorial Healthcare System
- Wayne State University
- Children's Mercy HospitalRecruiting
- Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)Recruiting
- The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
- Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
- Akron Nephrology Associates, Inc.Recruiting
- West Virginia UniversityRecruiting
- Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati KlinikaRecruiting
- University Of SzegedRecruiting
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
- Klaipeda Children's Hospital
- Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
- Instituto Mexicano De Trasplantes S.CRecruiting
- JM Research, SC
- Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
- Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)Recruiting
- Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
- Specjalistyczne Gabinety Sp. z o.o
- University Children Hospital
- Polish Mother's Memorial Hospital Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferumoxytol
Iron sucrose
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Full Information
NCT ID
NCT03619850
First Posted
August 3, 2018
Last Updated
July 18, 2023
Sponsor
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03619850
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMAG Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease; Iron Deficiency Anemia
Keywords
Iron deficiency anemia (IDA), chronic kidney disease (CKD), pediatrics, ferumoxytol, iron sucrose, Feraheme, Venofer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ferumoxytol
Arm Type
Experimental
Arm Title
Iron sucrose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Other Intervention Name(s)
Venofer
Intervention Description
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).
Primary Outcome Measure Information:
Title
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Description
Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Incidence of Treatment Emergent Adverse Events
Time Frame
49 days
Title
Incidence of adverse events of special interest (AESI)
Description
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Time Frame
49 days
Other Pre-specified Outcome Measures:
Title
Area Under the Curve (AUC)
Description
Pharmacokinetic parameter: Area Under the Curve (AUC)
Time Frame
35 days
Title
Clearance
Description
Pharmacokinetic parameter: clearance
Time Frame
35 days
Title
Distribution and elimination half-lives
Description
Pharmacokinetic parameter: distribution and elimination half-lives
Time Frame
35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Interest
Phone
1-877-374 -4177
Email
CTInterest@covispharma.com
Facility Information:
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Akron Nephrology Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
University Of Szeged
City
Szeged
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos
City
Kaunas
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Klaipeda Children's Hospital
City
Klaipėda
Country
Lithuania
Individual Site Status
Active, not recruiting
Facility Name
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
City
Vilnius
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Instituto Mexicano De Trasplantes S.C
City
Cuernavaca
Country
Mexico
Individual Site Status
Recruiting
Facility Name
JM Research, SC
City
Cuernavaca
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
City
Białystok
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Specjalistyczne Gabinety Sp. z o.o
City
Kraków
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
University Children Hospital
City
Kraków
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Polish Mother's Memorial Hospital Research Institute
City
Łódź
Country
Poland
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
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