Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT00353535
Status:
COMPLETED
Last Update Posted:
2006-07-18
First Post:
2006-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2002-12'}, 'lastUpdateSubmitDate': '2006-07-17', 'studyFirstSubmitDate': '2006-07-17', 'studyFirstSubmitQcDate': '2006-07-17', 'lastUpdatePostDateStruct': {'date': '2006-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant'}], 'secondaryOutcomes': [{'measure': 'Morbidity and mortality ot the treatment'}]}, 'conditionsModule': {'keywords': ['glomerulosclerosis, focal', 'pretransplant immunosuppression', 'total lymphoid irradiation', 'renal transplant', 'recurrence'], 'conditions': ['Glomerulosclerosis, Focal']}, 'descriptionModule': {'briefSummary': 'The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft', 'detailedDescription': 'Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (age \\> 18 years)\n* Biopsy-proven primary FSGS\n* End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.\n* Signed the informed consent before entering in the study.\n\nExclusion Criteria:\n\n* Age \\< or equal 18 years\n* No biopsy-proven FSGS\n* Without living donor to perform the transplant\n* No signed the informed consent'}, 'identificationModule': {'nctId': 'NCT00353535', 'briefTitle': 'Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft', 'orgStudyIdInfo': {'id': 'TLIFSGSusp'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total Lymphoid irradiation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Pedro Chocair, Prof. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil'}, {'name': 'Rosangela Villar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}}}}