Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 10:43 AM
Study NCT ID:
NCT00154206
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation'}], 'secondaryOutcomes': [{'measure': 'Within the 6 and 12 months post transplantation'}, {'measure': 'Incidence of acute rejection resistant to steroids'}, {'measure': 'Incidence of graft loss and death'}, {'measure': 'Renal function by creatinine and creatinine clearance (Schwartz formula)'}, {'measure': 'Incidence of premature study drug discontinuation due to safety reason'}, {'measure': 'Pharmacokinetic profile of Myfortic.'}, {'measure': 'Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.'}]}, 'conditionsModule': {'keywords': ['Enteric-coated mycophenolate sodium,', 'de novo,', 'renal transplantation,', 'pediatric', 'De novo pediatric renal transplantation'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '18985393', 'type': 'BACKGROUND', 'citation': 'Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipients of a primary renal transplantation\n* Recipients of a renal transplantation only\n\nExclusion Criteria:\n\n* Recipients of a multi-organ transplantation\n* Unable to take an oral medication\n* Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).\n\nOther protocol-defined inclusion / exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00154206', 'briefTitle': 'Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients', 'orgStudyIdInfo': {'id': 'CERL080AFR03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enteric-Coated Mycophenolate Sodium (EC-MPS)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}