Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 3:15 AM
Study NCT ID:
NCT00983034
Status:
COMPLETED
Last Update Posted:
2009-09-23
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'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': 'D009393', 'term': 'Nephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-22', 'studyFirstSubmitDate': '2009-09-21', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily proteinuria levels after Helicobacter Pylori eradication treatment', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Glomerular filtration rate', 'timeFrame': '6 months'}, {'measure': 'Serum creatinine level', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nephrotic syndrome', 'Helicobacter pylori infection', 'proteinuria', 'membranous nephropathy'], 'conditions': ['Nephrotic Syndrome', 'Glomerulonephritis', 'Membranous Nephropathy']}, 'referencesModule': {'references': [{'pmid': '24707402', 'type': 'DERIVED', 'citation': 'Caliskan B, Yazici H, Caliskan Y, Ozluk Y, Gulluoglu M, Kilicaslan I, Turkmen A, Sever MS. The Effects of Helicobacter pylori Eradication on Proteinuria in Patients with Primary Glomerulonephritis. Int J Nephrol. 2014;2014:180690. doi: 10.1155/2014/180690. Epub 2014 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'Membranous nephropathy (MN) may also be secondary to many other diseases (e.g., infections, drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori (H. pylori) antigen was investigated in renal tissue from needle biopsy samples, and the prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria level in patients with MN will be investigated.', 'detailedDescription': 'Membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. It is thought to be mainly a primary or idiopathic form; however, it may also be secondary to many other diseases (e.g., infections, drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori antigen was investigated in renal tissue from needle biopsy samples, and the prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria level in patients with MN will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-70 years\n* Nondiabetic patients\n* Patients with primary glomerulonephritis\n* Clinical diagnosis of membranous nephropathy, IgA nephropathy or focal segmental glomerulosclerosis confirmed by biopsy\n* Glomerular filtration rate \\> 30 mL/min\n* Patients who did not receive Helicobacter pylori eradication therapy within the last three months before enrollment in study\n\nExclusion Criteria:\n\n* Patients with secondary glomerulonephritis\n* Glomerular filtration rate \\< 30 mL/min\n* Patients who received Helicobacter pylori eradication therapy within the last three months before enrollment in study\n* Patients with a history of gastric surgery\n* Patients without an informed consent'}, 'identificationModule': {'nctId': 'NCT00983034', 'briefTitle': 'The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy', 'orgStudyIdInfo': {'id': '20061976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Membranous nephropathy', 'description': 'Patients with primary membranous nephropathy diagnosed by biopsy', 'interventionNames': ['Drug: lansoprazole, amoxicillin, clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IgA nephropathy', 'description': 'Patients with IgA nephropathy diagnosed by biopsy', 'interventionNames': ['Drug: lansoprazole, amoxicillin, clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Focal segmental glomerulosclerosis', 'description': 'Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy', 'interventionNames': ['Drug: lansoprazole, amoxicillin, clarithromycin']}], 'interventions': [{'name': 'lansoprazole, amoxicillin, clarithromycin', 'type': 'DRUG', 'description': 'lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days', 'armGroupLabels': ['Focal segmental glomerulosclerosis', 'IgA nephropathy', 'Membranous nephropathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yasar Caliskan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University'}, {'name': 'Berna Yelken, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University'}, {'name': 'Halil Yazici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University'}, {'name': 'Mehmet S Sever, Prof MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yasar Caliskan', 'oldOrganization': 'Division of Nephrology, Department of Intenal Medicine, Istanbul Faculty of Medicine, Istanbul University'}}}}