Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-02 @ 12:51 AM
Study NCT ID:
NCT00816504
Status:
WITHDRAWN
Last Update Posted:
2015-09-07
First Post:
2008-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005690', 'term': 'Galactose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Under additional IRB Review', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2008-12-31', 'studyFirstSubmitQcDate': '2008-12-31', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in FSGS permeability factor', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FSGS', 'Permeability factor', 'Galactose', 'Primary FSGS, resistant to immunosuppressive medication'], 'conditions': ['Focal Segmental Glomerulosclerosis']}, 'referencesModule': {'references': [{'pmid': '15384010', 'type': 'BACKGROUND', 'citation': 'Trachtman H, Greenbaum LA, McCarthy ET, Sharma M, Gauthier BG, Frank R, Warady B, Savin VJ. Glomerular permeability activity: prevalence and prognostic value in pediatric patients with idiopathic nephrotic syndrome. Am J Kidney Dis. 2004 Oct;44(4):604-10.'}]}, 'descriptionModule': {'briefSummary': 'This study is a proof-of-concept clinical study designed to test the hypothesis that oral administration of galactose can lower the level of a circulating factor that increases glomerular permeability to albumin in patients with resistant FSGS.', 'detailedDescription': 'Patients with resistant FSGS have persistent proteinuria and a high risk of progression to end stage kidney disease (ESKD). A circulating factor that increases glomerular permeability to albumin (Palb) has been detected in over 50% of these patients. While the molecular identity of the factor has not been fully established, in vitro studies and limited clinical experience suggest that galactose can reduce the level of the FSGS permeability factor.\n\nThis study is a pilot study to determine if oral administration of galactose can lower the circulating level of the FSGS permeability factor.\n\nFive patients with biopsy proven primary FSGS - native or transplant kidney, receiving plasmapheresis - who are resistant to steroids and one other immunosuppressive agents will be studied.\n\nThe only eligibility factor is presence of the FSGS permeability factor.\n\nThe experimental intervention is administration of galactose, orally, 0.2 g/kg body weight/dose twice daily. the duration of treatment will be 28 days,.\n\nPatients will be seen on days 0, 14, and 28 of treatment. They will be seen at week 8, 16 and 24 after discontinuation of the galactose.\n\nPhysical examination and routine laboratory tests (SMAC, CBC, urine protein:creatinine ratio in an early morning sample) will be done at each visit. The FSGS permeability factor will be assayed at days 0 and 28 of treatment and 6 months after discontinuation of the galactose. The permeability factor will be tested in the laboratory of Virginia Savin MD (Medical college of Wisconsin) using previously described methods.\n\nAll other treatments will be unchanged during the 28 day oral galactose Treatment Period.\n\nThe study will be analyzed based on the number of patients in whom the FSGS permeability factor is lowered to normal levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary FSGS\n* CKD Stage 5\n* Resistance to steroids and another immunosuppressive medication\n\nExclusion Criteria:\n\n* Secondary FSGS'}, 'identificationModule': {'nctId': 'NCT00816504', 'briefTitle': 'Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)and Chronic Kidney Disease Stage 5', 'orgStudyIdInfo': {'id': '08-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Galactose', 'interventionNames': ['Drug: Galactose']}], 'interventions': [{'name': 'Galactose', 'type': 'DRUG', 'description': 'Oral galactose, 0.2 g/kg/dose twice daily for 28 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Howard Trachtman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Schneider Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical College of Wisconsin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Howard Trachtman MD', 'investigatorAffiliation': 'Northwell Health'}}}}