Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-01 @ 2:56 PM
Study NCT ID:
NCT00154661
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005921', 'term': 'Glomerulonephritis'}], 'ancestors': [{'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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-06', 'completionDateStruct': {'date': '2001-06'}, 'lastUpdateSubmitDate': '2005-09-08', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proteinuria'}], 'secondaryOutcomes': [{'measure': 'inflammatory mediators'}]}, 'conditionsModule': {'keywords': ['glomerulonephritis'], 'conditions': ['Primary Glomerulonephritis']}, 'descriptionModule': {'briefSummary': 'we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis.', 'detailedDescription': 'Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment of peripheral vascular occlusive disorders. In addition, PTX has shown its ability to attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis, and to reduce subnephrotic proteinuria due to early and advanced diabetic nephropathy. However, data with respect to its effect on non-nephrotic primary glomerular diseases are lacking. Moreover, while the anti-proteinuric effect of PTX has been largely attributed to down-regulation of TNF-a, it remains unknown whether other mediators, especially MCP-1, are also affected by PTX. Because our previous works have shown that PTX attenuates proteinuria and suppresses renal MCP-1 mRNA expression in experimental glomerulonephritis in rats, we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis. This study was thereby conducted to investigate the potential anti-proteinuric and anti-MCP-1 effects of PTX in subnephrotic patients with primary glomerular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* glomerular diseases with subnephrotic proteinuria\n\nExclusion Criteria:\n\n* DM, hepatitis, systemic immunologic renal diseases'}, 'identificationModule': {'nctId': 'NCT00154661', 'briefTitle': 'Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis', 'orgStudyIdInfo': {'id': '152S2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pentoxifylline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Yung-Ming Chen', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Pan-Chyr Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor and vice-Dean'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}}}}