Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-09 @ 7:02 PM
Study NCT ID:
NCT02832505
Status:
WITHDRAWN
Last Update Posted:
2025-03-25
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applications of MRI in Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'due to the risk for the patient and later funding issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI measured perfusion for each patient group', 'timeFrame': 'Baseline', 'description': 'MRI measurements will be summarized for each patient group by using mean and standard deviation or standard error.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'End-stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study has two major purposes:\n\n1. To test developed multiple anatomic and functional MRI methods;\n2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.\n\nThese purposes will be achieved by performing pilot studies with cohorts of patients.', 'detailedDescription': 'This study is observational with no intervention applied for the patients. In this study, multiple anatomic and functional MRI methods will be performed with three cohorts of patients. In addition to anatomic MRI methods, non-contrast enhanced functional MRI methods will also be applied to evaluate tissue perfusion and vascular reactivity in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include three main cohorts of patients: 20 ESRD patients with their transition to dialysis treatment, 20 CKD controls and 20 non-CKD controls. Based on the investigators previous experience, about 20% of recruited subjects may not be able to finish the proposed studies. Therefore, a conservative estimate of the total number of subjects to be recruited is 72.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English-speaking as primary language\n2. Able to complete an approximately 75 to 90 minute cognitive and/or physical tests\n3. Capable to consent to studies\n\nExclusion Criteria:\n\n1. Acute psychiatric illness that would impede cognitive testing\n2. Active chemical dependence, such as alcohol, narcotics or other drugs\n3. Legally blind or unable to complete cognitive tests due to visual loss or deafness\n4. Renal transplant recipient at time of screening or baseline\n5. Severe CI unable to complete the Modified Mini-Mental State Examination \\[3MSE\\]\n6. Chronic and acute pulmonary disease'}, 'identificationModule': {'nctId': 'NCT02832505', 'briefTitle': 'Applications of MRI in Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Applications of MRI in Kidney Disease', 'orgStudyIdInfo': {'id': '1603M85321'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-CKD (Control)', 'description': 'Patients without CKD (eGFR ≥ 60 ml/min/1.73 mm2) (non-CKD controls).\n\nNo intervention but only observational.', 'interventionNames': ['Other: No intervention but only observational']}, {'label': 'CKD (chronic kidney disease)', 'description': 'Patients with Patients with moderate to severe CKD (eGFR ranging from 26 to 44 ml/min/1.73 mm2).\n\nNo intervention but only observational.', 'interventionNames': ['Other: No intervention but only observational']}, {'label': 'ESRD (end-stage renal disease)', 'description': 'Patients with advanced CKD (eGFR \\< 15 ml/min/1.73 mm2), preparing for or undergoing the standard thrice-weekly HD or standard PD treatment (end-stage renal disease (ESRD) patients).\n\nNo intervention but only observational.', 'interventionNames': ['Other: No intervention but only observational']}], 'interventions': [{'name': 'No intervention but only observational', 'type': 'OTHER', 'description': 'This study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied.', 'armGroupLabels': ['CKD (chronic kidney disease)', 'ESRD (end-stage renal disease)', 'Non-CKD (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Xiufeng Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}