Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00588120
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2007-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006959', 'term': 'Hyperoxaluria'}], 'ancestors': [{'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': 'D010070', 'term': 'Oxalates'}], 'ancestors': [{'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine oxalate measured following absorption of oral oxalate dose', 'timeFrame': '2 years', 'description': 'Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyperoxaluria', 'Unknown Hyperoxaluria', 'Enteric Hyperoxaluria', 'Oxaluric', 'High Oxalate', 'Oxalate', 'C13', 'Oxalate Diet'], 'conditions': ['Enteric Hyperoxaluria', 'Hyperoxaluria']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.", 'detailedDescription': "Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 4 years (patient must be able to void on request).\n* Have good health.\n\nExclusion Criteria:\n\n* Any prior history of renal disease, or hypertension\n* ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study.\n* Subjects with GFR \\< 50 cc/min will be excluded.'}, 'identificationModule': {'nctId': 'NCT00588120', 'briefTitle': 'Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study', 'orgStudyIdInfo': {'id': '1026-98'}, 'secondaryIdInfos': [{'id': 'RFA-OD-08-001', 'type': 'OTHER_GRANT', 'domain': 'Rare Diseases Clinical Research Consortia'}, {'id': '1U54DK083908-01', 'link': 'https://reporter.nih.gov/quickSearch/1U54DK083908-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-13 labeled oxalate', 'description': 'Hyperoxaluric patients', 'interventionNames': ['Drug: C-13 labeled oxalate']}], 'interventions': [{'name': 'C-13 labeled oxalate', 'type': 'DRUG', 'otherNames': ['oxalate'], 'description': 'A single prescribed dose of C-13 labeled oxalate will be given orally in capsule form or in jello. Urine will be collected for 24 hours after the dose.\n\nTake one capsule by mouth for one day.', 'armGroupLabels': ['C-13 labeled oxalate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Dawn Milliner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Oxalosis and Hyperoxaluria Foundation (OHF)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John Lieske', 'investigatorAffiliation': 'Mayo Clinic'}}}}