Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01038505
Status:
WITHDRAWN
Last Update Posted:
2024-06-03
First Post:
2009-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lost funding source', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the time to initiation of the comparison study', 'timeFrame': '3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Living Donor Kidney Transplants Patients']}, 'descriptionModule': {'briefSummary': 'The investigators center has also analyzed data over the last 7 years from deceased donor (DD) and living donor (LD) kidney transplant recipients who were randomized into 3 immunosuppressive arms between 2000 and 2001. Thus the goal of the investigators study is to reduce the toxic effects of traditional immunosuppressive regimens involving high-dose calcineurin inhibitor agents by comparing low-dose TAC-MYF with low-dose TAC and de novo SRL regimens. In order to minimize exposure to TAC, the investigators center has previously shown favorable outcomes using combination Thymoglobulin and Zenapax (Daclizumab) for anti-lymphocyte induction in the investigator population of patients.', 'detailedDescription': 'A total of 150 randomized patients divided into 2 arms: 75 patients will be randomized to receive TAC-SRL, and 75 patients to receive TAC-MYF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-HLA identical living donor kidney transplant patients\n\nExclusion Criteria:\n\n* Patient has previously received or is receiving an organ transplant other than a kidney.\n* Patient is receiving an ABO incompatible donor kidney.\n* Recipient or donor is known seropositive for human immunodeficiency (HIV) or Hepatitis C virus, or Hepatitis B virus antigenemia.\n* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully, or carcinoma in-situ of the cervix that has been treated successfully.\n* Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range at our center.\n* Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.\n* Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.\n* Patient will be receiving any immunosuppressive agent other than those prescribed in the study.\n* Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e., skin closure).\n* Patient is receiving or may require Warfarin, Fluvastatin, or herbal supplements during the study.\n* Concurrent use of Astemizole, Pimozide, Cisapride, Terfenadine, or Ketoconazole.\n* Patient has a known hypersensitivity to Tacrolimus, Thymoglobulin®, IL-2 receptor inhibitor monoclonal antibodies, Rapamune, Myfortic®, or corticosteroids.\n* Patient is pregnant or lactating.\n* Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count \\<4000/mm3; platelet count \\<100,000/mm3; fasting triglycerides \\>400 mg/dl (\\>4.6 mmol/L); fasting total cholesterol \\>300 mg/dl (\\>7.8 mmol/L); fasting HDL-cholesterol \\<30 mg/dl; fasting LDL-cholesterol \\>200 mg/dl.\n* Patient is unlikely to comply with the visits scheduled in the protocol.\n* Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.\n* If Tacrolimus cannot be instituted for longer than 5 days postoperatively.'}, 'identificationModule': {'nctId': 'NCT01038505', 'briefTitle': 'Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Head to Head Comparison of Tacrolimus and Myfortic vs Tacrolimus and Sirolimus Used in Combination in Non-HLA Identical Living Donor Kidney Transplants', 'orgStudyIdInfo': {'id': '20090531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus and Myfortic', 'description': 'Immunosuppressive', 'interventionNames': ['Drug: Tacrolimus, Myfortic and Sirolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus and Sirolimus', 'description': 'Immunosuppressive', 'interventionNames': ['Drug: Tacrolimus, Myfortic and Sirolimus']}], 'interventions': [{'name': 'Tacrolimus, Myfortic and Sirolimus', 'type': 'DRUG', 'description': 'Immunosuppressive drugs', 'armGroupLabels': ['Tacrolimus and Myfortic', 'Tacrolimus and Sirolimus']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Linda Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}