Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-05 @ 6:38 PM
Study NCT ID:
NCT00461357
Status:
UNKNOWN
Last Update Posted:
2007-04-18
First Post:
2007-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-04-17', 'studyFirstSubmitDate': '2007-04-17', 'studyFirstSubmitQcDate': '2007-04-17', 'lastUpdatePostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Old for Old', 'Eurotransplant Senior Program', 'Glomerular Filtration Rate'], 'conditions': ['Kidney Function After Transplantation', 'Outcome After Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities.\n\nThis prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL).\n\nThe aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipients of the Eurotransplant Senior Program\n* negative cytotoxic crossmatch\n* signed informed consent\n\nExclusion Criteria:\n\n* High sensitized recipients (PRA \\> 40%)\n* Non heart Beating Donor\n* Hyperlipidemia\n* Leucocytopenia (\\< 3000/mm3)\n* Thrombocytopenia (\\< 75000/mm3)'}, 'identificationModule': {'nctId': 'NCT00461357', 'acronym': 'ESP', 'briefTitle': 'Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program', 'orgStudyIdInfo': {'id': 'NTX-OFO-01'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ferdinand Muehlbacher, MD Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna; Department of Transplantation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}}}}