Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT00224003
Status:
COMPLETED
Last Update Posted:
2009-09-28
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C035552', 'term': 'ferric gluconate'}, {'id': 'D013395', 'term': 'Sucrose'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gary.hoel@watson.com', 'phone': '801-588-6641', 'title': 'Gary Hoel, RPh, PhD', 'organization': 'Watson Laboratories, Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Ferric Gluconate Complex'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '240.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 weeks', 'description': 'Change from baseline to 2 weeks after last Fe dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (completer) population', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.', 'timeFrame': '14 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Transferrin Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Ferric Gluconate Complex'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '11.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 weeks', 'description': 'Change from baseline to 2 weeks after last dose', 'unitOfMeasure': '%', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (completer) population', 'anticipatedPostingDate': '2009-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Ferric Gluconate Complex'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'First patient in: April 2, 2003', 'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Last patient out: March 31, 2004', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'unk', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Ferric Gluconate Complex'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '2.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-18', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-18', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Ferritin', 'timeFrame': '14 weeks', 'description': 'Change from baseline to 2 weeks after last Fe dose'}, {'measure': 'Transferrin Saturation', 'timeFrame': '14 weeks', 'description': 'Change from baseline to 2 weeks after last dose'}], 'secondaryOutcomes': [{'measure': 'Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anemia'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '16520948', 'type': 'RESULT', 'citation': 'Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female pediatric ESRD, Patients \\>\\_ 2 and \\<\\_ 16 years of age, whose legally authorized representative provided signed informed consent.\n* Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.\n* Predetermined TSAT and serum Ferritin (at the screening visit).\n* Receiving a stable EPO dosing regimen.\n\nExclusion Criteria:\n\n* Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.\n* Hypersensitivity to Ferrlecit or any of its inactive components.\n* High TSAT level.\n* High Serum Ferritin'}, 'identificationModule': {'nctId': 'NCT00224003', 'briefTitle': 'Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Watson Pharmaceuticals'}, 'officialTitle': 'Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin', 'orgStudyIdInfo': {'id': 'FRO2001'}, 'secondaryIdInfos': [{'id': 'FDA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sodium Ferric Gluconate Complex in Sucrose.', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Stanford', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Gary Hoel, RPh, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Watson Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gary Hoel, RPh, PhD Executive Director, Clinical Research', 'oldOrganization': 'Watson Laboratory, Inc'}}}}