Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-04-22 @ 5:05 AM
Study NCT ID:
NCT02435368
Status:
UNKNOWN
Last Update Posted:
2015-05-06
First Post:
2015-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood was obtained from healthy donors,mononuclear cells (PBMCs) were isolated using Ficoll density gradient centrifugation, and LPS (1 μg/ml) and/or MPA were added. After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-30', 'studyFirstSubmitDate': '2015-04-25', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean ± SD of percentage of IL-1β production induced by Lipopolysaccharide in associate with MPA in monocytes.', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'To determine the mechanisms and significances of synergistic effects of mycophenolic acid and LPS on IL-1β secretion by mononuclear', 'detailedDescription': 'Mycophenolate mofetil (MMF), which inhibits T and B lymphocyte proliferation, is widely used to treat a variety of autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN). We are the first to show that mycophenolic acid (MPA), the active metabolite of MMF, in association with lipopolysaccharide (LPS), is able to promote the secretion of interleukin (IL)-1β, which contradicts the traditional conception that immunosuppressants inhibit the secretion of inflammatory factors.\n\nIn this study, we first determined the effects of MPA in association with LPS on IL-1β production. Then, we explored whether the synergized effect on IL-1β production was mediated through the nuclear factor （NF）-κB pathway that produces more pro-IL-1β, or through the triggering of NLRP3 inflammasome that leads to enhanced activation of caspase-1 and accelerated degradation of pro-IL-1β into mature IL-1β.\n\nThis study is not only conducive to clarify the mechanisms, signal transduction pathways and potential clinical significances of IL-1β production in LPS and MPA combined treatment, but also to provide experimental data as well as theoretical rationales for more effective and more logical immunosuppressive protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteers,age 18-60.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy Volunteers，age 18-60.\n\nExclusion Criteria:\n\n* Don't agree with informed consent"}, 'identificationModule': {'nctId': 'NCT02435368', 'briefTitle': 'The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Third Affiliated Hospital of Southern Medical University'}, 'officialTitle': 'The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and Lipopolysaccharide on Interleukin-1β Secretion by Mononuclear', 'orgStudyIdInfo': {'id': '201501001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mycophenolic acid', 'type': 'DRUG', 'otherNames': ['mycophenolate mofetil'], 'description': 'Monocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'erwei Sun, doctor', 'role': 'CONTACT', 'email': 'ewsun@263.net', 'phone': '+86 020-62784421'}, {'name': 'xuechan Huang, doctor', 'role': 'CONTACT', 'email': 'flycicada@163.com', 'phone': '+86 15521116926'}], 'facility': 'Third Affiliated Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'erwei Sun, doctor', 'role': 'CONTACT', 'email': 'ewsun@263.net', 'phone': '+86 020-62784421'}, {'name': 'xuechan Huang, doctor', 'role': 'CONTACT', 'email': 'flycicada@163.com', 'phone': '+86 15521116926'}], 'overallOfficials': [{'name': 'erwei Sun, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Third Affiliated Hospital of Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Affiliated Hospital of Southern Medical University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.Xuechan Huang', 'investigatorFullName': 'Xuechan Huang', 'investigatorAffiliation': 'The Third Affiliated Hospital of Southern Medical University'}}}}