Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT01895894
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2013-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D009401', 'term': 'Nephrosis'}], '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': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-04', 'studyFirstSubmitDate': '2013-07-07', 'studyFirstSubmitQcDate': '2013-07-07', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relapse free time', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'adverse effect', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mycophenolate mofetil', 'Immunosuppressive Agents', 'Nephrosis'], 'conditions': ['Nephrotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '39513526', 'type': 'DERIVED', 'citation': 'Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.'}]}, 'descriptionModule': {'briefSummary': 'Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.\n\nMycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year\n* in complete remission\n\nExclusion Criteria:\n\n* Hereditary or secondary nephrotic syndrome\n* Estimated glomerular filtration rate (GFR) \\< 60 mg/min/1.73 m\\^2\n* Body weight \\<16 kg\n* leukocytopenia (absolute neutrophil count \\< 2000/mm\\^3) or anemia(Hct \\< 25%)\n* Severe gastrointestinal disease\n* chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)\n* prior live vaccine inoculation within 6 weeks (from the study enrollment)\n* GOT/GPT elevation or hyperbilirubinemia\n* malignant disease\n* Pregnant or Breast feeding\n* Previous history of mycophenolate mofetil use\n* Participation to other therapeutic trial within recent 3 months\n* Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase'}, 'identificationModule': {'nctId': 'NCT01895894', 'briefTitle': 'Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children', 'orgStudyIdInfo': {'id': 'MMF2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mycophenolate mofetil', 'interventionNames': ['Drug: Mycophenolate mofetil']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Myrept capsule/tablet'], 'description': 'Mycophenolate mofetil 20\\~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)', 'armGroupLabels': ['Mycophenolate mofetil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-740', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hee Gyung Aurea Kang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hee Gyung Kang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}