Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-05 @ 6:25 PM
Study NCT ID:
NCT07006532
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GFR', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cc/min/1.73 m'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant Rejection']}, 'descriptionModule': {'briefSummary': 'Chronic active antibody mediated rejection (CAMR) is a therapeutic challenge in transplant recipients that does not respond well to conventional treatments for acute antibody mediated rejection (AMR). Annually, 5000 kidney transplants are lost in the United States due to CAMR. The two-year graft survival rate in CAMR is approximately 20%, highlighting the need for a more efficient therapy for CAMR and directly targeting donor specific antibody (DSA) producing cells and reducing CAMRThere is no established treatment for this problem. While many centers intensify and optimize the dosage of immunosuppressive drugs, treatments such as plasmapheresis, IVIG, and rituximab, although effective in treating AMR, have not been successful in reducing DSA or improving kidney graft survival in CAMR patients. Despite these treatments, two-year graft survival can increase up to 55%. The use of anti-plasma cell treatments like bortezomib has also yielded inconsistent results.', 'detailedDescription': 'The trial is an open-labeled randomized clinical trial that evaluates the safety and efficacy of Tocilizumab as an add-on therapy to standard of care treatment of Plasmapheresis, IVIG, and Rituximab in treatment of CAMR in kidney transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent\n2. eGFR\\> 25 cc/min\n3. Chronicity index \\<8\n4. IFTA\\<40%\n5. EBV IgG positive\n\nExclusion Criteria:\n\n1. Active or recurrent infections\n2. History of malignancy, unless in remission for more than 2 years with no relapse\n3. abnormal liver function tests\n4. Platelet \\< 100,000'}, 'identificationModule': {'nctId': 'NCT07006532', 'briefTitle': 'Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab', 'orgStudyIdInfo': {'id': 'SBMU-1404-2/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Plasmapheresis plus Rituximab plus IVIG'}, {'type': 'OTHER', 'label': 'Intervention', 'description': 'Standard of care plus Tocilizumab', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'description': 'The trial is an open-labeled randomized clinical trial that evaluates the safety and efficacy of Tocilizumab as an add-on therapy to standard of care treatment of Plasmapheresis, IVIG, and Rituximab in treatment of CAMR in kidney transplant recipients.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1666663421', 'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Nooshin Dalili, Dr', 'role': 'CONTACT', 'email': 'nooshindalili4@gmail.com', 'phone': '00989122404331'}], 'facility': 'Nooshin Dalili', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'PI', 'role': 'CONTACT', 'email': 'dr.nooshindalili@gmail.com', 'phone': '00989122404331'}, {'name': 'PI', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'nooshin dalili', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}