- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619850
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)
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
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
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Clinical Trial Interest
- Phone Number: 1-877-374 -4177
- Email: CTInterest@covispharma.com
Study Locations
-
-
-
Budapest, Hungary
- Recruiting
- Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
-
Szeged, Hungary
- Recruiting
- University of Szeged
-
-
-
-
-
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)
-
-
-
-
-
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)
-
-
-
-
-
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
-
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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
|
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:
|
Active Comparator: 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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Urologic Diseases
- Disease Attributes
- Hematologic Diseases
- Renal Insufficiency
- Nutrition Disorders
- Anemia, Hypochromic
- Iron Metabolism Disorders
- Malnutrition
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Anemia, Iron-Deficiency
- Anemia
- Deficiency Diseases
- Iron Deficiencies
- Hematinics
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Ferrosoferric Oxide
- Ferric Oxide, Saccharated
Other Study ID Numbers
- AMAG-FER-CKD-354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Chronic Kidney Disease; Iron Deficiency Anemia
-
AMAG Pharmaceuticals, Inc.CompletedIron Deficiency Anemia Treatment | Chronic Kidney Disease(CKD)United States, Canada, United Kingdom
-
Universidade Federal FluminenseActive, not recruitingDysbiosis | Anemia of Chronic Kidney Disease | Chronic Renal Disease | Iron-Deficiency AnemiaBrazil
-
Pharmacosmos A/SCompletedChronic Kidney Disease | Iron Deficiency Anemia | Iron Deficiency AnaemiaUnited States
-
Vifor PharmaICON Clinical Research; American Regent, Inc.CompletedChronic Kidney Disease | Iron Deficiency AnaemiaUnited Kingdom, United States, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Turkey
-
Walid Ahmed Ragab AbdelhamidCompleted
-
Keryx BiopharmaceuticalsNot yet recruitingIron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
-
Keryx BiopharmaceuticalsCompletedIron Deficiency Anemia | Iron DeficiencyUnited States
-
AMAG Pharmaceuticals, Inc.TerminatedIron Deficiency Anemia | Nondialysis-dependent Chronic Kidney DiseaseUnited States
-
Keryx BiopharmaceuticalsCompletedAnemia of Chronic Kidney DiseaseIsrael
-
Northwestern UniversityNational Kidney FoundationCompletedChronic Kidney Diseases | Chronic Heart Failure | Iron Deficiency AnemiaUnited States
Clinical Trials on Iron sucrose
-
Xinhua Hospital, Shanghai Jiao Tong University...Completed
-
Richard FedorakCompletedIron Deficiency | Inflammatory Bowel DiseaseCanada
-
HaEmek Medical Center, IsraelWithdrawn
-
University of OxfordNational Center of Cardiology and Internal Medicine named after academician...WithdrawnHypertension, PulmonaryKyrgyzstan
-
Saskatchewan Health Authority - Regina AreaSaskatchewan Centre for Patient-Oriented ResearchRecruitingIron Deficiency Anaemia in ChildbirthCanada
-
University of OxfordCompleted
-
CN NGANOU-GNINDJIO, MD, MScCompletedIron Deficiency | Chronic Heart Failure (CHF)Cameroon
-
Papageorgiou General HospitalCompletedAnemia in Chronic Renal DiseaseGreece
-
Denver Health and Hospital AuthorityNational Trauma Research InstituteCompleted
-
Hospital Clinic of BarcelonaUnknownHip Fracture | Surgical InterventionSpain