Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-29 @ 2:54 AM
Study NCT ID:
NCT00255450
Status:
COMPLETED
Last Update Posted:
2008-11-11
First Post:
2005-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Crossover Safety Study of Ferumoxytol Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-10', 'studyFirstSubmitDate': '2005-11-17', 'studyFirstSubmitQcDate': '2005-11-17', 'lastUpdatePostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.'}]}, 'conditionsModule': {'keywords': ['anemia'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '16088081', 'type': 'BACKGROUND', 'citation': 'Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.'}, {'pmid': '18824288', 'type': 'RESULT', 'citation': 'Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis. 2008 Nov;52(5):907-15. doi: 10.1053/j.ajkd.2008.08.001. Epub 2008 Sep 27.'}, {'pmid': '37651553', 'type': 'DERIVED', 'citation': 'Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.'}], 'seeAlsoLinks': [{'url': 'http://www.kidney.org/index.cfm', 'label': 'National Kidney Foundation'}]}, 'descriptionModule': {'briefSummary': 'This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.', 'detailedDescription': 'This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients \\> 18 years.\n* Have chronic kidney disease per K/DOQI guidelines.\n* Baseline hemoglobin of \\> 9.0 and \\< 12.5 g/dl\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Received another investigational drug or device within 30 days.\n* Recent parenteral or oral iron therapy.\n* Patients that have other causes of anemia.\n* Major surgery within 30 days or anticipated or planned surgery during the study.\n* Patients with active infections.\n* Recent blood transfusions.\n* Patients with known allergies to iron products.'}, 'identificationModule': {'nctId': 'NCT00255450', 'briefTitle': 'A Crossover Safety Study of Ferumoxytol Versus Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'AMAG Pharmaceuticals, Inc.'}, 'officialTitle': 'A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo', 'orgStudyIdInfo': {'id': '62745-8'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ferumoxytol or placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94041', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, 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