Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 4:34 PM
Study NCT ID:
NCT00097968
Status:
COMPLETED
Last Update Posted:
2010-07-12
First Post:
2004-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'statusVerifiedDate': '2010-07', 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2004-12-01', 'studyFirstSubmitQcDate': '2004-12-01', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiac Events at 3 and 6 months.'}, {'measure': 'Patient survival at 3 and 6 months.'}, {'measure': 'Treated acute rejection at 3 and 6 months.'}, {'measure': 'Admission to the hospital at 3 and 6 months.'}, {'measure': 'Premature study treatment discontinuation at 3 and 6 months.'}]}, 'conditionsModule': {'keywords': ['transplant, heart, adult, everolimus', 'allograft rejection'], 'conditions': ['Graft Rejection']}, 'descriptionModule': {'briefSummary': 'Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation.\n\nIt is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography.\n* Patient must be on statins at study entry.\n* Patient who is more than 12 months post-transplant.\n\nExclusion Criteria:\n\n* Patient with a serum creatinine value \\>2.0 mg/dL.\n* Patient with a biopsy-proven acute rejection episode (\\>= ISHLT 3A) within 6 months prior to study entry.\n* Patient who had received any investigational drug within 4 weeks prior to study entry.'}, 'identificationModule': {'nctId': 'NCT00097968', 'briefTitle': 'Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy', 'orgStudyIdInfo': {'id': 'CRAD001A2405'}, 'secondaryIdInfos': [{'id': 'RAD/Certican'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'everolimus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, Fairfield University Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Presbyterian Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Midstate Cardiology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Richard Dorent, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}}}}