Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01382303
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2011-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LKW65@ajou.ac.kr', 'phone': '82-31-219-4526', 'title': 'Kwan Woo Lee', 'organization': 'Ajou University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day', 'otherNumAtRisk': 87, 'otherNumAffected': 20, 'seriousNumAtRisk': 87, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day', 'otherNumAtRisk': 87, 'otherNumAffected': 3, 'seriousNumAtRisk': 87, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nasea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Proteinuia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-23', 'groupId': 'OG000', 'lowerLimit': '-50', 'upperLimit': '10'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-30', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Changes of urine protein to creatinie ratio from baseline to 24 weeks', 'unitOfMeasure': '% change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Albuminuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000', 'lowerLimit': '-47', 'upperLimit': '50'}, {'value': '-6', 'groupId': 'OG001', 'lowerLimit': '-45', 'upperLimit': '41'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Changes of urine albumin to creatinie ratio from baseline to 24 weeks', 'unitOfMeasure': '% change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of eGFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '18.20', 'groupId': 'OG000'}, {'value': '-3.59', 'spread': '14.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes in eGFR from baseline to 24 weeks', 'unitOfMeasure': 'ml/min per 1.73m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes serum creatinine from baseline to 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '38.9', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '37.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes serum fasting glucose from baseline to 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of TNF-a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes in TNF-a from baseline to 24 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day\n\nPentoxifylline: Pentoxifylline 400mg three times a day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo tablet\n\nPlacebo: placebo tablet three times a day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.7', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2011-06-22', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2011-06-24', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-31', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Proteinuia', 'timeFrame': 'baseline and 24 weeks', 'description': 'Changes of urine protein to creatinie ratio from baseline to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage Change in Albuminuria', 'timeFrame': 'baseline and 24 weeks', 'description': 'Changes of urine albumin to creatinie ratio from baseline to 24 weeks'}, {'measure': 'Mean Change of eGFR', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes in eGFR from baseline to 24 weeks'}, {'measure': 'Mean Change of Creatinine', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes serum creatinine from baseline to 24 weeks'}, {'measure': 'Mean Change of Fasting Glucose', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes serum fasting glucose from baseline to 24 weeks'}, {'measure': 'Mean Change of TNF-a', 'timeFrame': 'baseline and 24 weeks', 'description': 'changes in TNF-a from baseline to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'pentoxifylline', 'proteinuria'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37916745', 'type': 'DERIVED', 'citation': 'Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.'}, {'pmid': '26300986', 'type': 'DERIVED', 'citation': 'Han SJ, Kim HJ, Kim DJ, Sheen SS, Chung CH, Ahn CW, Kim SH, Cho YW, Park SW, Kim SK, Kim CS, Kim KW, Lee KW. Effects of pentoxifylline on proteinuria and glucose control in patients with type 2 diabetes: a prospective randomized double-blind multicenter study. Diabetol Metab Syndr. 2015 Jul 19;7:64. doi: 10.1186/s13098-015-0060-1. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.', 'detailedDescription': 'The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.\n\nEnrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.\n\nFasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.\n\nThe investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus\n* age \\>=20 years\n* spot urine albumin/creatinine ratio \\> 30mg/g in two consecutive measurements\n* patients on ACE-inhibitor or ARB as an anti-hypertensive drug\n* blood pressure \\<= 150/100 mmHg\n* HbA1c \\<10%\n\nExclusion Criteria:\n\n* taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months\n* ischemic heart disease, stroke, malignant disease, severe infection in 6 months\n* serum creatinine \\> 2.0mg/dl\n* severe liver disease or AST, ALT \\> 3\\* ULM\n* taking systemic steroid in 1 month\n* pregnant or plan to become pregnant during the clinical trial\n* lactation'}, 'identificationModule': {'nctId': 'NCT01382303', 'briefTitle': 'Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study', 'orgStudyIdInfo': {'id': 'AJIRB-MED-CT4-10-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pentoxifylline', 'description': 'Pentoxifylline 400mg three times a day', 'interventionNames': ['Drug: Pentoxifylline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pentoxifylline', 'type': 'DRUG', 'otherNames': ['Trental'], 'description': 'Pentoxifylline 400mg three times a day', 'armGroupLabels': ['Pentoxifylline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo tablet three times a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Kwan-Woo Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bundang CHA Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Yonsei University', 'class': 'OTHER'}, {'name': 'Myongji Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Kwan Woo Lee', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}