Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-08 @ 1:53 AM
Study NCT ID:
NCT02628106
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], '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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000527', 'term': 'Alprostadil'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wangcaizi2@163.com', 'phone': '+86 13795581617', 'title': 'Mr.Zhi-cheng Li', 'organization': 'West China Hospital of Sichuan University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'the small study population and absence of a placebo group and healthy volunteers.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'We assessed the 21 participants, but none of the participants had serious Adverse Event', 'eventGroups': [{'id': 'EG000', 'title': 'Diabetic Nephropathy,Chronic Kidney Disease', 'description': 'all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetic Nephropathy,Chronic Kidney Disease', 'description': 'all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '22.04', 'spread': '6.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after 14days of lipo-PGE1 intravenously', 'description': 'the R2\\* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2\\* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue', 'unitOfMeasure': '1/ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A random sample, west China hospital, in accord with a standard 21 people,age \\> 18 years'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diabetic Nephropathy,Chronic Kidney Disease', 'description': 'all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Our overall recruiting cycle for 40 days, mainly for patients with chronic kidney disease patients, which is divided into diabetic nephropathy and non-diabetic patients', 'preAssignmentDetails': 'Chronic kidney disease patients were divided into diabetic nephropathy and non-diabetic group, ordinary chronic kidney disease patients with diabetes mellitus were excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lipo-prostaglandin E1', 'description': 'all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.\n\nLipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'All applicable patients with CKD were eligible for this study. Other inclusion criteria were as follows: an age \\> 18 years and a diagnosis of type 2 diabetes based on the definition of the World Health Organization', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'men and women randomly, but try to match proportion', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'A random sample, west China hospital, in accord with a standard 21 people', 'unitOfMeasure': 'participants'}, {'title': 'R2* values', 'classes': [{'categories': [{'measurements': [{'value': '23.32', 'spread': '6.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Deoxyhemoglobin, as an endogenous contrast agent, is paramagnetic; the change in deoxyhemoglobin level can cause inhomogeneity in the magnetic field in the local tissue. R2\\* is a measure of the tissue content of deoxyhemoglobin, which is inversely proportional to the oxygen content in tissue. Thus, a decrease in R2\\* implies decreased deoxyhemoglobin concentrations and increased oxygen content in tissue.', 'unitOfMeasure': '1/ms', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'age \\> 18 years'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2015-12-01', 'resultsFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-14', 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI', 'timeFrame': 'baseline and after 14days of lipo-PGE1 intravenously', 'description': 'the R2\\* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2\\* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and after lipo-PGE1 administration to acquire bilateral renal cortical R2\\*(CR2\\*) and medullary R2\\* (MR2\\*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.', 'detailedDescription': 'R2\\* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks, Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. The R2\\* map was windowed from 0 to 60 s-1.\n\nRegions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. Three ROIs were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral cortex and medulla. To prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. Thereafter, assuming the tests were coincident, the results were the averaged.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic kidney disease\n\nExclusion Criteria:\n\n* Intolerance to lipo-PGE1, contraindication for MRI, concurrent urinary tract infection, acute kidney injury, acute cardiovascular and cerebrovascular complications and diabetic emergencies, with the use of corticosteroid and diureses.'}, 'identificationModule': {'nctId': 'NCT02628106', 'briefTitle': 'Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients', 'orgStudyIdInfo': {'id': 'BOLD-1981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipo-prostaglandin E1', 'description': 'all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.', 'interventionNames': ['Drug: Lipo-PGE1']}], 'interventions': [{'name': 'Lipo-PGE1', 'type': 'DRUG', 'otherNames': ['alprostadil'], 'description': 'all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days', 'armGroupLabels': ['Lipo-prostaglandin E1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Zhichengli', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'fang liu, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Nephrology, West China Hospital of Sichuan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A graduate student', 'investigatorFullName': 'Zhicheng Li', 'investigatorAffiliation': 'West China Hospital'}}}}