Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
Study NCT ID:
NCT00600951
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2008-01-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fixed tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-31', 'studyFirstSubmitDate': '2008-01-14', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate and compare the incidence of NSF in the two cohorts defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients.', 'timeFrame': '1, 3, 6, 12, 18 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'The objective of this long-term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2 - patients with severe chronic kidney disease or kidney failure eGFR \\<30).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 1000 patients in 2 cohorts who are going to receive or have received MULTIHANCE during an MRI examination as part of their routine clinical management. The cohorts are defined as:\n\nCOHORT 1 - 600 patients of any age, with moderate CKD (stage 3, i.e., with eGFR stably comprised between 30 and 59 mL/min/1.73m2); COHORT 2 - 400 patients of any age, with severe CKD or kidney failure (stages 4 and 5, i.e., with eGFR below 30 mL/min/1.73m2).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCOHORT 1\n\n* Is going to receive or has received MULTIHANCE injection during an MRI examination;\n* Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the MULTIHANCE injection.\n* Provides written informed consent and is willing to comply with protocol requirements.\n\nOR\n\nCOHORT 2\n\n* Is going to receive or has received MULTIHANCE injection during an MRI examination;\n* Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the MULTIHANCE injection.\n* Provides written informed consent and is willing to comply with protocol requirements.\n\nExclusion Criteria:\n\nCOHORT 1\n\n* Has received a GBCA within the past 12 months prior to inclusion in this study;\n* Has unstable kidney function;\n* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;\n* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;\n* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.\n\nOR\n\nCOHORT 2\n\n* Has received a GBCA within the past 12 months prior to inclusion in this study;\n* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;\n* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;\n* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.'}, 'identificationModule': {'nctId': 'NCT00600951', 'briefTitle': 'Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracco Diagnostics, Inc'}, 'officialTitle': 'A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injection of MultiHance', 'orgStudyIdInfo': {'id': 'MH-136'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with moderate chronic kidney disease (stage 3, according to the classification of chronic kidney disease by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2)'}, {'label': '2', 'description': 'Patients with severe chronic kidney disease or kidney failure (stages 4 and 5, according to the classification of chronic kidney disease by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08543', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bracco Diagnostics Inc.', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Gianpaolo Pirovano, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bracco Diagnostics, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}