Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-25 @ 4:11 PM
Study NCT ID:
NCT01284257
Status:
WITHDRAWN
Last Update Posted:
2017-02-27
First Post:
2011-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Registry Study of Renal Transplant Patients
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'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2011-01-25', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of EC-MPS or MMF over time', 'timeFrame': '60 months', 'description': 'Dosage interruptions, discontinuations and switches between EC-MPS and MMF'}], 'secondaryOutcomes': [{'measure': 'Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications', 'timeFrame': '60 months'}, {'measure': 'The incidence of selected Adverse Events', 'timeFrame': '60 months', 'description': 'e.g., viral infections, hematological events, glaucoma, malignancy, diabetes mellitus, cardiovascular events, bone-loss related events, GI events, hepatitis) and associated Serious Adverse Events (SAEs).'}, {'measure': 'Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death', 'timeFrame': '60 months'}, {'measure': 'Center Practices', 'timeFrame': '60 months', 'description': 'The center practice will be described as observed. This includes the number of transplants performed per year per center, patient follow up frequency, performance of protocol biopsies, use of induction therapies and MPA monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EC-MPS', 'MMF', 'kidney transplant', 'outcomes', 'mycophenolate sodium', 'mycophenolic acid (MPA)'], 'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll approximately 1,200 de novo (newly transplanted within 2 weeks) renal transplant patients from approximately 30-60 transplant centers across the United States. Patients should be consented prior to the first dose of MPA, +/- 14 days from the date of the transplant and be enrolled as soon as feasible after transplantation but not later than 2 weeks post-transplantation. Enrollment targets will be capped globally at 800 patients being treated with myfortic® and 400 patients being treated with CellCept®.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.\n* Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.\n* Able to provide informed consent.\n* Able to self-administer the ITAS compliance instrument (6 questions).\n\nExclusion Criteria:\n\n* The recipient of multiple organ grafts or prior non-kidney graft.\n* Enrolled or plans to enroll in an investigational clinical trial.\n* Not likely to have up to 5 year follow-up data available for this study.'}, 'identificationModule': {'nctId': 'NCT01284257', 'acronym': 'MORE registry', 'briefTitle': 'Observational Registry Study of Renal Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'CERL080AUS40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enteric coated mycophenolate sodium (EC-MPS) arm', 'description': 'Patients to whom EC-MPS is prescribed by their practitioner.'}, {'label': 'MMF arm', 'description': 'Patients to whom MMF is prescribed by their practitioner.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco investigational site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Investigational site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Springfield investigational site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit investigational site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York investigational site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'PHILADELPHIA investigational site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'BURLINGTON investigational site', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle investigational site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}