Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT02355704
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-01-30', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-Reactive Protein evolution in donors', 'timeFrame': 'Basal and 4 weeks later', 'description': 'C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later. The last blood sample was taken the day of surgical procedure.'}, {'measure': 'Kidney graft rejection using scale of BANFF', 'timeFrame': 'Basal, 3 months and 12 months', 'description': 'During surgical procedure and before organ transplantation, basal biopsy was obtain. In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy. Alterations between groups were registered.'}], 'secondaryOutcomes': [{'measure': 'Kidney function evolution after transplant', 'timeFrame': '24 hours, 3 months and 12 months', 'description': 'In blood samples, after kidney transplantation, creatinine and urea were measured. Differences in evolution and alteration between the 2 groups were registered'}, {'measure': 'Interleukin and tumor necrosis factor alpha.', 'timeFrame': 'Basal', 'description': 'During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.'}, {'measure': 'Complications', 'timeFrame': '24 hours, 3 months and 12 months', 'description': 'During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney Transplantation', 'Atorvastatin', 'C-Reactive Protein', 'Biopsy', 'Interleukin'], 'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.\n\nRecently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.', 'detailedDescription': 'Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.\n\nMaterial and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 48 patients, randomized manner, realized at the Transplant Department of Western Medical Center, Mexican Institute of Social Security. Universe was patients accepted as kidney donors. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff\n\nThe statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accepted as kidney donor\n* Voluntary participation\n* Informed consent accepted\n* 85% fulfillment of atorvastatin treatment\n\nExclusion Criteria:\n\n* Hypersensibility to Atorvastatin\n* Smoking'}, 'identificationModule': {'nctId': 'NCT02355704', 'briefTitle': 'Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo', 'orgStudyIdInfo': {'id': '2011-1301-78'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': '22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '22 patients received oral placebo 40 mg 1 time for day for 4 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure controls were performed', 'armGroupLabels': ['Atorvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Homologated Placebo'], 'description': 'Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure were performed', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Western Medical Center, Mexican Institute of Social Security', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Clotilde Fuentes-Orozco, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Mexicano del Seguro Social'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'CLOTILDE FUENTES OROZCO', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}