Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-09 @ 2:45 AM
Study NCT ID:
NCT00560820
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077588', 'term': 'Deferasirox'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2007-11-19', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.', 'timeFrame': 'Once a month'}], 'secondaryOutcomes': [{'measure': 'Effect of deferasirox on standard markers of renal function', 'timeFrame': 'Once a month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['β-thalassemia', 'transfusional iron overload', 'renal function', 'renal biomarkers', 'deferasirox'], 'conditions': ['β-thalassemia', 'Transfusional Iron Overload']}, 'referencesModule': {'references': [{'pmid': '25402221', 'type': 'DERIVED', 'citation': 'Piga A, Fracchia S, Lai ME, Cappellini MD, Hirschberg R, Habr D, Wegener A, Bouillaud E, Forni GL. Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent beta thalassaemia. Br J Haematol. 2015 Mar;168(6):882-90. doi: 10.1111/bjh.13217. Epub 2014 Nov 17.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7823', 'label': 'Results for CICL670A2123 can be found on the Novartis Clinical Trials Results Website'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or female patients ≥ 18 years of age without prior history of deferasirox treatment\n* β-thalassemia patients receiving regular transfusions every 2-5 weeks\n* Transfusion history of ≥ 20 units of packed red blood cells\n\nExclusion criteria:\n\n* Abnormal renal function at baseline\n* ALT greater than 5 x ULN at screening\n* Patients with underlying cardiac disease requiring continuous iron chelation therapy\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00560820', 'briefTitle': 'Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload', 'orgStudyIdInfo': {'id': 'CICL670A2123'}, 'secondaryIdInfos': [{'id': '2006-006838-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deferasirox', 'description': '30 mg/kg/day', 'interventionNames': ['Drug: Deferasirox']}], 'interventions': [{'name': 'Deferasirox', 'type': 'DRUG', 'otherNames': ['ICL670'], 'description': '30 mg/kg/day', 'armGroupLabels': ['Deferasirox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09121', 'city': 'Cagliari', 'state': 'CA', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '16128', 'city': 'Genova', 'state': 'GE', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '10043', 'city': 'Orbassano', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmeceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}