Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 12:43 AM
Study NCT ID:
NCT01989832
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmaco-economical Study in Kidney Transplantation
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': 570}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Death', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'to examine nature, dose and exposure in immunosuppresseurs.', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cohort', 'pharmaco-economic', 'kidney', 'transplantation', 'quality of life'], 'conditions': ['Renal Transplant']}, 'descriptionModule': {'briefSummary': 'The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases …).\n\nAccording to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices.\n\nEPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'renal transplant patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the first month of renal graft, or patients already included in an other epidemiological French study (EPIGREN) in the 0-6 month period\n* Men of women aged more than 18 years\n* Patients able to exercise in writing their informed and free consent to participate to the biological collection\n* Patients not opposing to collect their medical data\n* Patients registered with a social security system\n* Patients able to complete the questionnaires\n\nExclusion Criteria:\n\n* Patients aged less than 18 years and patients under guardianship\n* Patients with a follow-up at another center other than those part of the study'}, 'identificationModule': {'nctId': 'NCT01989832', 'acronym': 'EPHEGREN', 'briefTitle': 'Pharmaco-economical Study in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Pharmaco-economical Study in Kidney Transplantation', 'orgStudyIdInfo': {'id': 'I10007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biological and clinical Data collected'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87 042', 'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}