Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT02343094
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenylbutyrate in Proteinuric Nephropathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Lcn2/creatinine ratio', 'timeFrame': 'Day 7, Day 15, Day 21, Day 28', 'description': 'Reduction of 50 % of Lcn2 concentration, measured with ELISA'}], 'secondaryOutcomes': [{'measure': 'Urinary protein/creatinine ratio', 'timeFrame': 'Day 7', 'description': 'Reduction of 30% of the proteinurie and the albuminuria'}, {'measure': 'Urinary protein/creatinine ratio', 'timeFrame': 'Day 15', 'description': 'Reduction of 30% of the proteinurie and the albuminuria'}, {'measure': 'Urinary protein/creatinine ratio', 'timeFrame': 'Day 21', 'description': 'Reduction of 30% of the proteinurie and the albuminuria'}, {'measure': 'Urinary protein/creatinine ratio', 'timeFrame': 'Day 28', 'description': 'Reduction of 30% of the proteinurie and the albuminuria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proteinuria', 'Lipocalin 2', 'Neutrophil gelatinase associated lipocalin', 'ELISA'], 'conditions': ['Proteinuric Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.', 'detailedDescription': 'Proteinuria is a major prognosis factor of chronic kidney disease (CKD) progression. Convergent evidences from clinical and experimental studies indicate that albuminuria and proteinuria are not simply a marker of CKD progression, but an active player in the evolution of the disease. Mechanistically, it has been shown that proteinuria induces endoplasmic reticulum stress in tubular cells, leading to induction of lipocalin 2/NGAL, a critical element of CKD progression. Moreover, proteinuric mice treated with phenylbutyrate are protected from CKD progression.\n\nThe aim of this study is to evaluate the efficacy of phenybutyrate, a molecular chaperone which inhibits ER stress, on the proteinuria-induced NGAL expression. Urinary NGAL/creatinine ratio will be evaluated in proteinuric patients before and under treatment with phenylbutyrate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Kidney disease for ore than 3 months\n* Proteinuria \\> 1g/d or 0,1g/mmmol creatinine\n* eGFR \\>30ml/mn/1,73m2\n* written informed consent\n* affiliated with social security health insurance\n\nExclusion Criteria:\n\n* Women with childbearing potential\n* Recent (\\<3 months) modification of ACE inhibitors or ARB\n* Acute renal failure\n* eGFR \\<30ml/mn/1,73m2\n* Nephrotic syndrome (albuminélia \\<30g/l)\n* Infection with HIV, HCV, HBV\n* Liver insufficiency\n* No affiliated with social security health insurance\n* inclusion in another protocol of biomedical research\n* risk of non-adherence to protocol and visits\n* patients having a cardiac insufficiency of grade 3 or 4\n* patient requiring of a strict salt-free diet\n* patients under corticoids or immunosuppresseurs\n* clinical intolerance in the treatment\n* intolerance in the fructose, the syndrome of malabsorption glucose and galactose or a deficit in sucrase / isomaltase\n* patients treated by Probenecide'}, 'identificationModule': {'nctId': 'NCT02343094', 'acronym': 'PIRATE', 'briefTitle': 'Phenylbutyrate in Proteinuric Nephropathies', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients', 'orgStudyIdInfo': {'id': '2013-003924-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBA 7,5g/d', 'description': 'Treatment for 14 days', 'interventionNames': ['Drug: PBA 7,5g/d']}, {'type': 'EXPERIMENTAL', 'label': 'PBA 15g/d', 'description': 'Treatment for 14 days', 'interventionNames': ['Drug: PBA 15g/d']}], 'interventions': [{'name': 'PBA 7,5g/d', 'type': 'DRUG', 'description': 'Treatment for 14 days with PBA', 'armGroupLabels': ['PBA 7,5g/d']}, {'name': 'PBA 15g/d', 'type': 'DRUG', 'description': 'Treatment for 14 days with PBA', 'armGroupLabels': ['PBA 15g/d']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bertrand KNEBELMANN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Néphrologie Adulte, Hôpital Necker'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}