Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT01318967
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2011-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Measurement of Kidney Blood Flow and Oxygen Levels by MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mrocco@wfubmc.edu', 'phone': '336-716-4650', 'title': 'Michael Rocco, MD', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Furosemide', 'description': 'With and without furosemide\n\nFurosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement of Renal Blood Flow of the Kidney by the PAH Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Furosemide', 'description': 'With and without furosemide\n\nFurosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.\n\nRenal blood flow is measured by PAH method and by MRI method'}], 'classes': [{'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '342'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Renal blood flow is estimated over 1 hour by PAH', 'description': 'Renal blood flow is estimated by the PAH method.', 'unitOfMeasure': 'ml/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measurement of Regional Blood Oxygenation by MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRI After Furosemide', 'description': 'After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow\n\nFurosemide: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.'}], 'classes': [{'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '620'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One measure after furosemide (day 1)', 'description': 'Estimate of renal blood flow by using MRI scans before and after the administration of furosemide', 'unitOfMeasure': 'ml/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Furosemide', 'description': 'With and without furosemide\n\nFurosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Furosemide', 'description': 'With and without furosemide\n\nFurosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2011-03-18', 'resultsFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-08', 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Renal Blood Flow of the Kidney by the PAH Method', 'timeFrame': 'Renal blood flow is estimated over 1 hour by PAH', 'description': 'Renal blood flow is estimated by the PAH method.'}], 'secondaryOutcomes': [{'measure': 'Measurement of Regional Blood Oxygenation by MRI', 'timeFrame': 'One measure after furosemide (day 1)', 'description': 'Estimate of renal blood flow by using MRI scans before and after the administration of furosemide'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Renal blood flow', 'Regional renal blood flow', 'MRI'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Comparison of renal blood flow measurements by PAH clearance and MRI', 'detailedDescription': 'The traditional measurement of renal blood flow in ml/min involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.\n\nExclusion Criteria:\n\nThis study excludes those not suitable for MRI or for the interventional pharmacologic procedures.'}, 'identificationModule': {'nctId': 'NCT01318967', 'briefTitle': 'Measurement of Kidney Blood Flow and Oxygen Levels by MRI', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation', 'orgStudyIdInfo': {'id': 'IRB00010832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PAH', 'description': 'PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MRI after furosemide', 'description': 'After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow', 'interventionNames': ['Drug: Furosemide']}], 'interventions': [{'name': 'Furosemide', 'type': 'DRUG', 'otherNames': ['Lasix'], 'description': 'Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.', 'armGroupLabels': ['MRI after furosemide']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['PAH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Michael Rocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}