Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-03 @ 10:38 PM
Study NCT ID:
NCT00310557
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2006-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}], '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'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019786', 'term': 'Gadolinium DTPA'}], 'ancestors': [{'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-28', 'studyFirstSubmitDate': '2006-03-31', 'studyFirstSubmitQcDate': '2006-03-31', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy, sensitivity and specificity based on quantitative assessment of stenosis', 'timeFrame': 'Image creation after injection - evaluation at blind read'}], 'secondaryOutcomes': [{'measure': 'Diagnostic confidence', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Difference in degree of stenosis', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Other diagnostic findings', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Localisation matching of maximum stenosis', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Image quality', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Image evaluability and presence of artifacts', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Proportions of correctly categorised arteries with regard to maximum stenosis', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Number of evaluable arteries', 'timeFrame': 'At blinded and/or open label read of images'}, {'measure': 'Patient management', 'timeFrame': 'From baseline to 24 hours follow-up'}, {'measure': 'Safety', 'timeFrame': 'From baseline to 24 hours follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The results will be compared to the results of MRI taken without Magnevist and with the results of your X-ray angiography.', 'detailedDescription': 'This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Has known or suspected renal artery disease - Is scheduled for X-ray angiography Exclusion Criteria: - Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previously had stents placed bilaterally in the region to be imaged'}, 'identificationModule': {'nctId': 'NCT00310557', 'briefTitle': 'Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Open-label Study of the Safety (Open-label) and Efficacy (Open-label and Blinded Reader) of a Single Administration of Approximately 0.1 mmol/kg of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients With Known or Suspected Renal Artery Disease Undergoing MRA of the Renal Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference', 'orgStudyIdInfo': {'id': '90940'}, 'secondaryIdInfos': [{'id': '304629'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Gadopentetate dimeglumine (Magnevist)']}], 'interventions': [{'name': 'Gadopentetate dimeglumine (Magnevist)', 'type': 'DRUG', 'description': 'Approximately 0.1mmol/kg body weight, single intravenous administration on the study day', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}