Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT04983160
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells', 'timeFrame': 'Data collected after 4 weeks, 8 weeks and 12 weeks.', 'description': 'Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD'}], 'secondaryOutcomes': [{'measure': 'Level of oxidative stress', 'timeFrame': 'After patient visit (0 weeks, 4, 8 and 12 weeks)', 'description': 'Evaluated through quantification of oxygen-reactive species'}, {'measure': 'Level of micro inflammation', 'timeFrame': 'After patient visit (0 weeks, 4, 8 and 12 weeks)', 'description': 'Evaluated through quantification of C-reactive protein, proinflammatory cytokines, CD14+ and CD16+ monocytes'}, {'measure': 'Level of endothelial dysfunction', 'timeFrame': 'After patient visit (0 weeks, 4, 8 and 12 weeks)', 'description': 'Endothelium-dependant vasodilation in response to ischemia evaluated through changes in capillar flux using Doppler laser PeriFlux system 5000'}, {'measure': 'Blood pressure', 'timeFrame': 'Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours'}, {'measure': 'Glomerular filtration ratio', 'timeFrame': 'After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)', 'description': 'Estimated through MDRD-4 y Cockroft-Gault.'}, {'measure': 'Microalbuminuria / Proteinuria', 'timeFrame': 'Daily, using first urine of the day as a sample.', 'description': 'Evaluated through albumin/creatinin ratio and protein/creatinine ratio'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'allopurinol', 'CKD'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms.', 'detailedDescription': 'The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms, evaluating the plasma concentration of angiogenic factors, microparticles of endothelial cells and the cell number circulating endothelial progenitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients willing and able to give informed consent for participation in the study\n* Ability to understand study procedures and to comply with it for the duration of the study.\n* Subjects of both sexes, the age range between 18 and 70 years old.\n* Serum uric acid above 7 mg / dl.\n* Estimated glomerular filtration rate by MDRD abbreviated formula less than 60 ml / min / 1.73 m2 and above 15 ml / min / 1.73 m2.\n* Stability of renal function (serum creatinine increase without exceeding 50% in the three months before the start of the study).\n* Clinically stable in terms of no hospitalizations of cardiovascular events in the 3 months before the study began.\n\nExclusion Criteria:\n\n* Drop active in the 60 days prior to study initiation.\n* Use of allopurinol within 60 days preceding baseline\n* Active infections within 30 days prior to baseline.\n* Patients with systemic inflammatory disease\n* Infection with HIV, Hepatitis C and Hepatitis B.\n* History of cancer within 5 years prior to the first dose of study medication\n* Chronic liver disease.\n* Immunosuppressive therapy.\n* Pregnant women, breastfeeding or planning to become pregnant.\n* Allergy or sensitive to allopurinol.\n* Addiction to drugs or alcohol, in the opinion of the investigator, may interfere with compliance with study requirements.\n* Inability or unwillingness of the individual or legal guardian or representative to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT04983160', 'briefTitle': 'Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial. Modulation of Cellular Mediators and Repair Endothelial Damage in Patients With Chronic Renal Disease Through Inhibition of Xanthine Oxidase', 'orgStudyIdInfo': {'id': 'PI12/01866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol', 'interventionNames': ['Drug: Allopurinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Allopurinol', 'armGroupLabels': ['Allopurinol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14002', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía de Córdoba', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Rafael Santamaría, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Reina Sofía'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}