Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT00505102
Status:
UNKNOWN
Last Update Posted:
2008-02-13
First Post:
2007-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Renal Function In Long Term Heart Transplanted Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-02-12', 'studyFirstSubmitDate': '2007-07-19', 'studyFirstSubmitQcDate': '2007-07-19', 'lastUpdatePostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney Diseases', 'Heart Transplantation', 'Everolimus', 'Cyclosporine Toxicity'], 'conditions': ['Kidney Diseases', 'Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '12954741', 'type': 'BACKGROUND', 'citation': 'Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.'}, {'pmid': '17346627', 'type': 'BACKGROUND', 'citation': "Rothenburger M, Teerling E, Bruch C, Lehmkuhl H, Suwelack B, Bara C, Wichter T, Hinder F, Schmid C, Stypmann J. Calcineurin inhibitor-free immunosuppression using everolimus (Certican) in maintenance heart transplant recipients: 6 months' follow-up. J Heart Lung Transplant. 2007 Mar;26(3):250-7. doi: 10.1016/j.healun.2007.01.017."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart Transplant patients with more than 1 year of follow-up\n* Creatinine lower than 3.5 mg/dl\n* GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)\n* Cyclosporine in maintenance immunosuppressive therapy\n* Patient must be able to sign an approve informed consent\n* Prior History of acute rejection within the last 3 months\n* Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used\n\nExclusion Criteria:\n\n* Patients who are recipients of multiple organ transplants\n* Prior or current use of sirolimus or everolimus\n* History of acute rejection within the last 6 months\n* Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months\n* Patient not able to attend all follow-up evaluations'}, 'identificationModule': {'nctId': 'NCT00505102', 'acronym': 'SAREFU', 'briefTitle': 'Safe Renal Function In Long Term Heart Transplanted Patients', 'organization': {'class': 'OTHER', 'fullName': 'A.O. Ospedale Papa Giovanni XXIII'}, 'officialTitle': 'Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients', 'orgStudyIdInfo': {'id': 'SAREFU123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Everolimus']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'description': 'cyclosporine dose reduced of 50% after introduction of everolimus', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Heart Transplant Center Ospedali Riuniti', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '24100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Heart Transplantad Center OspedaliRiuniti Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}], 'overallOfficials': [{'name': 'Roberto Fiocchi, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heart Transplant Center Ospedali Riuniti Bergamo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O. Ospedale Papa Giovanni XXIII', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Roberto Fiocchi', 'oldOrganization': 'Ospedali Riuniti Bergamo'}}}}