Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 9:38 AM
Study NCT ID:
NCT02016235
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Role Of Phosphorus And FGF 23 In Patients With Dent Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057973', 'term': 'Dent Disease'}], 'ancestors': [{'id': 'D015499', 'term': 'Renal Tubular Transport, Inborn Errors'}, {'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': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lieske.John@mayo.edu', 'phone': '507-266-7960', 'title': 'John C. Lieske, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected over a period of 7 days for each subjects', 'eventGroups': [{'id': 'EG000', 'title': 'Dent Disease Intervention', 'description': 'Dent Disease subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Kidney Stone Subjects', 'description': 'Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dent Disease Observation', 'description': 'Dent disease subjects will not get phosphorus\n\nObservation: Baseline blood and urine measurements only. Day 7 Urine total protein not obtained', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urine Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dent Disease Intervention', 'description': 'Dent Disease subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid'}, {'id': 'OG001', 'title': 'Kidney Stone Subjects', 'description': 'Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid'}, {'id': 'OG002', 'title': 'Dent Disease Observation', 'description': 'Dent disease subjects will not get phosphorus\n\nObservation: Baseline blood and urine measurements only. Day 7 Urine total protein not obtained'}], 'classes': [{'categories': [{'measurements': [{'value': '1681', 'spread': '979', 'groupId': 'OG000'}, {'value': '59', 'spread': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, day 7', 'description': 'Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for the Disease Dent Observation Group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dent Disease Intervention', 'description': 'Dent Disease subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid'}, {'id': 'FG001', 'title': 'Kidney Stone Subjects', 'description': 'Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid'}, {'id': 'FG002', 'title': 'Dent Disease Observation', 'description': 'Dent disease subjects will not get phosphorus\n\nObservation: Baseline blood and urine measurements only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dent Disease Intervention', 'description': 'Dent Disease subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid'}, {'id': 'BG001', 'title': 'Kidney Stone Subjects', 'description': 'Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus\n\nPhosphorus Supplement: 250 mg po qid'}, {'id': 'BG002', 'title': 'Dent Disease Observation', 'description': 'Dent disease subjects will not get phosphorus\n\nObservation: Baseline blood and urine measurements only'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.4', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '30.6', 'spread': '9.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-15', 'size': 5238187, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-30T11:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2013-12-06', 'resultsFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2013-12-13', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-19', 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urine Total Protein', 'timeFrame': 'baseline, day 7', 'description': 'Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dent', 'Dents', 'Dent Disease', 'Phosphorus Supplements', 'FGF 23'], 'conditions': ['Dent Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials.', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be recruited from those in the RKSC Dent Registry\n\n1. Diagnostic criteria for Dent disease Observational arm include:\n\n 1. \\<18 years old\n 2. LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria: 1. Hypercalciuria, 2. Kidney stones, 3. Nephrocalcinosis, 4. Hypophosphatemia, 5. Renal phosphate leak, 6. Aminoaciduria, 7. Glucosuria without diabetes mellitus, 8. Hematuria, 9. Renal insufficiency, 10. Family history with x-linked inheritance or\n 3. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.\n2. Diagnostic criteria for Dent disease Intervention arm include:\n\n 1. \\>18 years old\n 2. LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria: 1. Hypercalciuria, 2. Kidney stones, 3. Nephrocalcinosis, 4. Hypophosphatemia, 5. Renal phosphate leak, 6. Aminoaciduria, 7. Glucosuria without diabetes mellitus, 8. Hematuria, 9. Renal insufficiency, 10. Family history with x-linked inheritance or\n 3. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.\n3. Idiopathic calcium nephrolithiasis with renal phosphate leak\n\n 1. Male patients \\> 18 years old\n 2. History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (\\>250 mg/24 hrs), renal phosphate leak (TMP/GFR \\<2.07 mg/dl)\n4. Idiopathic calcium nephrolithiasis without renal phosphate leak\n\n 1. Male patients \\> 18 years old\n 2. History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (\\>250 mg/24 hrs), renal phosphate leak (TMP/GFR \\<2.07 mg/dl)\n\nExclusion Criteria:\n\n1. Exclusion for Dent disease include: primary or secondary hyperparathyroidism, hyperthyroidism, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.\n2. Exclusion criteria for calcium stone formers include: primary or secondary hyperparathyroidism, hyperthyroidism, estimated GFR \\<40 ml/mn/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.\n3. Exclusion criteria include history of symptomatic or asymptomatic kidney stone disease; primary or secondary hyperparathyroidism; estimated GFR \\<40 ml/min/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.'}, 'identificationModule': {'nctId': 'NCT02016235', 'briefTitle': 'Role Of Phosphorus And FGF 23 In Patients With Dent Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Role Of Phosphorus And FGF 23 In Patients With Dent Disease', 'orgStudyIdInfo': {'id': '13-004774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dent Disease Intervention', 'description': 'Dent Disease subjects will receive 2 week supplementation with phosphorus', 'interventionNames': ['Drug: Phosphorus Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Kidney Stone subjects', 'description': 'Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus', 'interventionNames': ['Drug: Phosphorus Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dent Disease Observation', 'description': 'Dent disease subjects will not get phosphorus', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Phosphorus Supplement', 'type': 'DRUG', 'otherNames': ['K-phos neutral'], 'description': '250 mg po qid', 'armGroupLabels': ['Dent Disease Intervention', 'Kidney Stone subjects']}, {'name': 'Observation', 'type': 'OTHER', 'description': 'Baseline blood and urine measurements only', 'armGroupLabels': ['Dent Disease Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'John C Lieske, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'John Lieske', 'investigatorAffiliation': 'Mayo Clinic'}}}}