Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 5:00 AM
Study NCT ID:
NCT01707550
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of CellCept (Mycophenolate Mofetil) in Renal Allograft Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average dose of CellCept used in immunosuppressive protocols in Serbia', 'timeFrame': '9 months'}, {'measure': 'Average dose of concomitant immunosuppressive drugs', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Average duration of post-transplant period for patients in Serbia receiving CellCept', 'timeFrame': '9 months'}]}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'This observational survey study will capture all renal transplant patients in Serbia who are currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Renal allograft recipients receiving CellCept as part of their immunosuppressive protocol', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Recipients of renal allograft\n* Patients receiving CellCept\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01707550', 'briefTitle': 'An Observational Study of CellCept (Mycophenolate Mofetil) in Renal Allograft Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Observational, Non-interventional Survey of Renal Allograft Recipients Receiving CellCept as Part of Their Immunosuppressive Protocol', 'orgStudyIdInfo': {'id': 'ML25048'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '18000', 'city': 'Niš', 'country': 'Serbia', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}