Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-08 @ 3:30 AM
Study NCT ID:
NCT00261820
Status:
COMPLETED
Last Update Posted:
2006-05-19
First Post:
2005-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'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'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2006-05-17', 'studyFirstSubmitDate': '2005-12-02', 'studyFirstSubmitQcDate': '2005-12-02', 'lastUpdatePostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-'}, {'measure': 'transplantation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff'}, {'measure': 'criteria at 3, 6 and 12 Months following transplantation'}, {'measure': 'One year graft biopsy status'}, {'measure': 'Incidence of document infection'}]}, 'conditionsModule': {'keywords': ['Kidney Transplant'], 'conditions': ['Graft Rejection', 'Kidney Failure', 'Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 and \\< 65 years\n* End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor\n* Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant\n\nExclusion Criteria:\n\n* Evidence of active systemic or localized major infection at the time of initial sirolimus administration\n* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening\n* Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase'}, 'identificationModule': {'nctId': 'NCT00261820', 'briefTitle': 'Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids', 'orgStudyIdInfo': {'id': '0468E1-100194'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tacrolimus', 'type': 'DRUG'}, {'name': 'mycophenolate mofetil', 'type': 'DRUG'}, {'name': 'methylprednisolone', 'type': 'DRUG'}, {'name': 'prednisolone', 'type': 'DRUG'}, {'name': 'sirolimus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Belgium, trials-BEL@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For France, infomedfrance@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}