Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01502267
Status:
UNKNOWN
Last Update Posted:
2012-01-06
First Post:
2011-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'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': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2011-12-24', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rates of kidney transplantation', 'timeFrame': 'from one to five years'}], 'secondaryOutcomes': [{'measure': 'Reduction in anti-HLA alloantibodies', 'timeFrame': '1year'}, {'measure': 'Renal allograft survival', 'timeFrame': 'from one to five year', 'description': 'graft and patient survival'}, {'measure': 'The number of serious complication', 'timeFrame': 'from one to five year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Waiting list', 'Deceased donor kidney transplantation', 'Desensitization', 'anti HLA antibody'], 'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '26844479', 'type': 'DERIVED', 'citation': 'Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.', 'detailedDescription': 'HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* patients who are on the waiting list more than 4 years\n* PRA I or II \\> 50%\n\nExclusion Criteria:\n\n* Recent recipients of any live attenuated vaccine(s) within 4 weeks\n* Subjects who have received IVIG or B cell depleting agents previously\n* Subjects with positive result for viral hepatitis(B,C) or HIV infection\n* Subjects with active infection\n* Lactating or pregnant females\n* Subjects who have history of malignancy in recent 5years\n* Subjects who have experience of treatment for the psychiatric problem in recent 6months\n* Subjects who have hematologic abnormality (Hb \\< 7g/dL, Platelet \\< 100,000/mm3, AST/ALT \\> 80IU)'}, 'identificationModule': {'nctId': 'NCT01502267', 'briefTitle': 'Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients', 'orgStudyIdInfo': {'id': '11374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1', 'description': 'This group will not receive IVIG and B cell depleting agents'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'This group will receive IVIG and B cell depleting agents', 'interventionNames': ['Drug: High dose IVIG and B cell depleting agents']}], 'interventions': [{'name': 'High dose IVIG and B cell depleting agents', 'type': 'DRUG', 'otherNames': ['IVIG', 'Mabthera', 'Velcade'], 'description': '1. IVIG(2g/kg two times on day 1, 30)\n2. Rituximab(375mg/m2 on day 3)\n3. Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-799', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Curie Ahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}