Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 10:19 AM
Study NCT ID:
NCT00852969
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Niacin and Endothelial Function in Early CKD
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': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msarnak@tuftsmedicalcenter.org', 'phone': '617 636-1182', 'title': 'Mark Sarnak, MD', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the trial up to 14 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Niacin', 'description': 'Niacin : 1000 mg tablets once per day', 'otherNumAtRisk': 15, 'otherNumAffected': 10, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance', 'otherNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'joint pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Flow Mediated Dilation From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin', 'description': 'Niacin : 1000 mg tablets once per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '-2.36', 'upperLimit': '8.50'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '-6.81', 'upperLimit': '9.56'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.69', 'ciLowerLimit': '-10.79', 'ciUpperLimit': '7.41', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '14 weeks since baseline', 'description': 'Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks', 'unitOfMeasure': 'absolute percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL-C From Baseline to 14 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Niacin', 'description': 'Niacin : 1000 mg tablets once per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance'}], 'classes': [{'categories': [{'measurements': [{'value': '5.22', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '9.25'}, {'value': '2.74', 'groupId': 'OG001', 'lowerLimit': '-0.13', 'upperLimit': '5.61'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.48', 'ciLowerLimit': '-7.20', 'ciUpperLimit': '2.24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '14 weeks since baseline', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Niacin', 'description': 'Niacin : 1000 mg tablets once per day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011', 'preAssignmentDetails': 'There was no washout period. Patients receiving Niacin were excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Niacin', 'description': 'Niacin : 1000 mg tablets once per day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'These were the number of individuals who agreed to be randomized for the study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-03', 'studyFirstSubmitDate': '2009-02-26', 'resultsFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2009-02-26', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-03', 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Flow Mediated Dilation From Baseline', 'timeFrame': '14 weeks since baseline', 'description': 'Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in HDL-C From Baseline to 14 Weeks', 'timeFrame': '14 weeks since baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Niacin', 'HDL', 'Endothelial Function'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CKD Stage 2 (GFR \\>60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)\n* HDL-cholesterol \\<50 for men and \\<55 for women\n* If taking a statin, stable dose for past one month\n* Glucose \\<200 mg/dL and HbA1c \\<9%\n* Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry\n\nExclusion Criteria:\n\n* Hospitalization within prior 3 months\n* Any of the following conditions:\n\n * uncontrolled peptic ulcer disease\n * active liver disease OR abnormal SGOT/SGPT\n * history of adverse reaction to niacin\n * contra-indication to aspirin\n * concurrent fibrate therapy\n * history of gout\n * serum phosphorus levels below 2.7mg/dl\n* Nursing\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00852969', 'briefTitle': 'Niacin and Endothelial Function in Early CKD', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?', 'orgStudyIdInfo': {'id': '5R21DK077368', 'link': 'https://reporter.nih.gov/quickSearch/5R21DK077368', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5R21DK077368-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21DK077368-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Niacin', 'interventionNames': ['Drug: Niacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Active Placebo']}], 'interventions': [{'name': 'Niacin', 'type': 'DRUG', 'otherNames': ['Niaspan'], 'description': '1000 mg tablets once per day', 'armGroupLabels': ['Niacin']}, {'name': 'Active Placebo', 'type': 'DRUG', 'description': '100 mg Niacin tablets once per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Mark Sarnak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}