Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 1:20 AM
Study NCT ID:
NCT03619850
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2018-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}, {'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 129}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2018-08-03', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Area Under the Curve (AUC)', 'timeFrame': '35 days', 'description': 'Pharmacokinetic parameter: Area Under the Curve (AUC)'}, {'measure': 'Clearance', 'timeFrame': '35 days', 'description': 'Pharmacokinetic parameter: clearance'}, {'measure': 'Distribution and elimination half-lives', 'timeFrame': '35 days', 'description': 'Pharmacokinetic parameter: distribution and elimination half-lives'}], 'primaryOutcomes': [{'measure': 'Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5', 'timeFrame': '35 days', 'description': 'Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events', 'timeFrame': '49 days', 'description': 'Incidence of Treatment Emergent Adverse Events'}, {'measure': 'Incidence of adverse events of special interest (AESI)', 'timeFrame': '49 days', 'description': 'Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron deficiency anemia (IDA)', 'chronic kidney disease (CKD)', 'pediatrics', 'ferumoxytol', 'iron sucrose', 'Feraheme', 'Venofer'], 'conditions': ['Chronic Kidney Disease; Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\nTo 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\n\nSecondary Objective:\n\nTo determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.', 'detailedDescription': '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.\n\nTotal subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period.\n\nSubjects receive the following:\n\n• 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\n\nOR\n\n• 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female 2 years to \\<18 years of age at time of consent\n2. 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\n3. Has Chronic Kidney Disease defined as one of the following:\n\n 1. on chronic hemodialysis;\n 2. receiving chronic peritoneal dialysis;\n 3. estimated glomerular filtration rate (eGFR) of \\<60 mL/min/1.73 m2;\n 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.\n4. 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\n5. 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\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose\n2. History of allergy to intravenous (IV) iron\n3. History of multiple drug allergies (\\>2)\n4. Low systolic blood pressure (Age 1-9 years \\<70 + \\[age in years x 2\\] mmHg, Age 10-17 years \\<90 mmHg)\n5. Hemoglobin ≤7.0 g/dL\n6. Serum ferritin level \\>600 ng/mL'}, 'identificationModule': {'nctId': 'NCT03619850', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AMAG Pharmaceuticals, Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'AMAG-FER-CKD-354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferumoxytol', 'interventionNames': ['Drug: Ferumoxytol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron sucrose', 'interventionNames': ['Drug: Iron sucrose']}], 'interventions': [{'name': 'Ferumoxytol', 'type': 'DRUG', 'otherNames': ['Feraheme'], '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.', 'armGroupLabels': ['Ferumoxytol']}, {'name': 'Iron sucrose', 'type': 'DRUG', 'otherNames': ['Venofer'], '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).', 'armGroupLabels': ['Iron sucrose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Memorial Healthcare System', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'The Feinstein Institute Medical Research Organization of Northwell Health, Inc.', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)", 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44302', 'city': 'Akron', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Akron Nephrology Associates, Inc.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Szeged', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'University Of Szeged', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Kaunas', 'status': 'NOT_YET_RECRUITING', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian University of Health Sciences Kauno klinikos', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Klaipėda', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Lithuania', 'facility': "Klaipeda Children's Hospital", 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'city': 'Vilnius', 'status': 'NOT_YET_RECRUITING', 'country': 'Lithuania', 'facility': "Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)", 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Cuernavaca', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Instituto Mexicano De Trasplantes S.C', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'city': 'Cuernavaca', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Mexico', 'facility': 'JM Research, SC', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'city': 'Guadalajara', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Hospital Civil de Guadalajara Fray Antonio Alcalde', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'facility': 'Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Bialystok', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Krakow', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Poland', 'facility': 'Specjalistyczne Gabinety Sp. z o.o', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'University Children Hospital', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': "Polish Mother's Memorial Hospital Research Institute", 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Clinical Trial Interest', 'role': 'CONTACT', 'email': 'CTInterest@covispharma.com', 'phone': '1-877-374 -4177'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}