Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00275535
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
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': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2006-01-10', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation', 'timeFrame': '12 months following transplantation', 'description': 'Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.'}], 'secondaryOutcomes': [{'measure': 'GFR (iothalamate clearance) at other time points', 'timeFrame': '24 months'}, {'measure': 'Other measures of renal function (serum creatinine, proteinuria and albuminuria)', 'timeFrame': '24 months'}, {'measure': 'Acute rejection both early and after tacrolimus withdrawal', 'timeFrame': '24 months'}, {'measure': 'Patient and graft survival', 'timeFrame': '24 months after transplantation'}, {'measure': 'Complications-especially hypertension, diabetes, dyslipidemia', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney transplantation', 'immunosuppression', 'calcineurin inhibitor', 'sirolimus', 'chronic allograft nephropathy'], 'conditions': ['Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '18431244', 'type': 'RESULT', 'citation': 'Dean PG, Grande JP, Sethi S, Park WD, Griffin MD, Cosio FG, Larson TS, Stegall MD. Kidney transplant histology after one year of continuous therapy with sirolimus compared with tacrolimus. Transplantation. 2008 Apr 27;85(8):1212-5. doi: 10.1097/TP.0b013e31816a8ae6.'}, {'pmid': '16468960', 'type': 'RESULT', 'citation': 'Larson TS, Dean PG, Stegall MD, Griffin MD, Textor SC, Schwab TR, Gloor JM, Cosio FG, Lund WJ, Kremers WK, Nyberg SL, Ishitani MB, Prieto M, Velosa JA. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant. 2006 Mar;6(3):514-22. doi: 10.1111/j.1600-6143.2005.01177.x.'}]}, 'descriptionModule': {'briefSummary': 'This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.', 'detailedDescription': 'The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant\n* Pediatric patients (\\<18 years of age)\n* Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)\n* ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)\n* Patients with severe hyperlipidemia (serum cholesterol \\>350 mg/dl or serum triglycerides \\>500 mg/dl\n* Patients with severe leukopenia (White Blood Cell count \\[WBC\\]\\<3000 10\\^3/ml)\n* Patients unwilling to return to the transplant center for late follow-up visits\n* Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon'}, 'identificationModule': {'nctId': 'NCT00275535', 'briefTitle': 'The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients', 'orgStudyIdInfo': {'id': '124-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus', 'description': 'Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.', 'interventionNames': ['Drug: Anti-thymocyte globulin', 'Drug: Mycophenolate mofetil', 'Drug: Prednisone', 'Drug: Tacrolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus', 'description': 'Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.', 'interventionNames': ['Drug: Anti-thymocyte globulin', 'Drug: Mycophenolate mofetil', 'Drug: Prednisone', 'Drug: Sirolimus']}], 'interventions': [{'name': 'Anti-thymocyte globulin', 'type': 'DRUG', 'otherNames': ['Thymoglobulin', 'Atgam'], 'description': 'Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)', 'armGroupLabels': ['Sirolimus', 'Tacrolimus']}, {'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['CellCept'], 'description': 'Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance', 'armGroupLabels': ['Sirolimus', 'Tacrolimus']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Deltasone', 'Liquid Pred', 'Meticorten', 'Orasone', 'Prednicen-M', 'Prednicot', 'Sterapred', 'Sterapred DS'], 'description': 'Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92', 'armGroupLabels': ['Sirolimus', 'Tacrolimus']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf', 'Advagraf', 'Protopic'], 'description': 'Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)', 'armGroupLabels': ['Tacrolimus']}, {'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml', 'armGroupLabels': ['Sirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mark D. Stegall, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark D. Stegall, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}