Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 3:36 AM
Study NCT ID:
NCT01228903
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Uric Acid and the Endothelium in CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'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': 'diana.jalal@ucdenver.edu', 'phone': '3037244867', 'title': 'Diana Jalal', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.\n\nPlacebo: Placebo tablets with no active ingredient', 'otherNumAtRisk': 41, 'otherNumAffected': 9, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Allopurinol', 'description': 'Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.\n\nAllopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.', 'otherNumAtRisk': 39, 'otherNumAffected': 4, 'seriousNumAtRisk': 39, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'GI discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Abnormal Liver Function Tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Death', 'notes': 'One patient died in the allopurinol arm, and it was attributed to a cardiovascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Endothelial Dependent Dilation From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo: Placebo tablets with no active ingredient'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol: Xanthine oxidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.7', 'estimateComment': 'The estimated value represents the difference between the change from baseline in both groups.', 'groupDescription': 'The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-reactive Protein From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo: Placebo tablets with no active ingredient'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol: Xanthine oxidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '00.42', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Interleukin-6 From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo: Placebo tablets with no active ingredient'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol: Xanthine oxidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo: Placebo tablets with no active ingredient'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol: Xanthine oxidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '45.8', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '36.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '-4.7'}, {'type': 'SECONDARY', 'title': 'Change in Oxidized Low Density Lipoprotein From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo: Placebo tablets with no active ingredient'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol: Xanthine oxidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': '16.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'u/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Serum Uric Acid Levels From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo: Placebo tablets with no active ingredient'}, {'id': 'OG001', 'title': 'Allopurinol', 'description': 'Allopurinol: Xanthine oxidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Serum uric acid levels were measured both at baseline and after 12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.\n\nPlacebo: Placebo tablets with no active ingredient'}, {'id': 'FG001', 'title': 'Allopurinol', 'description': 'Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.\n\nAllopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.\n\nPlacebo: Placebo tablets with no active ingredient'}, {'id': 'BG001', 'title': 'Allopurinol', 'description': 'Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.\n\nAllopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '55.9', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2010-10-25', 'resultsFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-03', 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Serum Uric Acid Levels From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Serum uric acid levels were measured both at baseline and after 12 weeks'}], 'primaryOutcomes': [{'measure': 'Change in Endothelial Dependent Dilation From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12'}], 'secondaryOutcomes': [{'measure': 'Change in C-reactive Protein From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Serum Interleukin-6 From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Oxidized Low Density Lipoprotein From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['uric acid kidney disease endothelial dysfunction'], 'conditions': ['Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '32964203', 'type': 'DERIVED', 'citation': 'Perrenoud L, Kruse NT, Andrews E, You Z, Chonchol M, Wu C, Ten Eyck P, Zepeda-Orozco D, Jalal D. Uric Acid Lowering and Biomarkers of Kidney Damage in CKD Stage 3: A Post Hoc Analysis of a Randomized Clinical Trial. Kidney Med. 2020 Feb 26;2(2):155-161. doi: 10.1016/j.xkme.2019.11.007. eCollection 2020 Mar-Apr.'}], 'seeAlsoLinks': [{'url': 'http://en.wikipedia.org/wiki/Endothelium', 'label': 'What is the endothelium?'}]}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease', 'detailedDescription': 'The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:\n\n1\\) Allopurinol therapy and 2) Placebo.\n\nPatients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2\n* Elevated uric acid levels\n* Age range: more than 18 years old\n* Ability to give informed consent\n* Albumin \\> 3.0 g/dL\n* BMI \\< 40 kg/m2\n\nExclusion Criteria:\n\n* Life expectancy \\< 1.0 years\n* Expected to undergo living related kidney transplant in 6 months\n* Pregnant, breast feeding, or unwilling to use adequate birth control\n* History of severe liver disease\n* History of severe congestive heart failure\n* History of hospitalizations within 3 months\n* Active infection, on antibiotics\n* History of Warfarin Use or other medications that are contraindicated with allopurinol\n* Uncontrolled hypertension\n* History of acute gout on Allopurinol\n* History of adverse reaction to Allopurinol\n* Immunosuppressive therapy within the last 1 yr'}, 'identificationModule': {'nctId': 'NCT01228903', 'briefTitle': 'Uric Acid and the Endothelium in CKD', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?', 'orgStudyIdInfo': {'id': '10-0625'}, 'secondaryIdInfos': [{'id': 'K23DK088833', 'link': 'https://reporter.nih.gov/quickSearch/K23DK088833', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol', 'description': 'Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.', 'interventionNames': ['Drug: Allopurinol']}], 'interventions': [{'name': 'Allopurinol', 'type': 'DRUG', 'otherNames': ['Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.'], 'description': 'Xanthine oxidase inhibitor- effective at lowering uric acid levels.', 'armGroupLabels': ['Allopurinol']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo tablets with no active ingredient', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado at Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Diana Jalal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data will be made available to investigators upon request from the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}