Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-02-08 @ 6:47 AM
Study NCT ID:
NCT02032095
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative rate of FCXM-T after the fourth administration of GB-0998', 'timeFrame': 'at 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVIG', 'Renal transplantation', 'desensitization'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stage 4 or 5 on the CKD classification.\n* Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.\n* Patients with positive FCXM-T after performing twice DFPP therapy\n\nExclusion Criteria:\n\n* Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.\n* Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.\n* Patients who had Rituximab within 6 month before to informed consent.\n* Patients who have undergone splenectomy.\n* Patients with severe hepatic disorder or severe heart disorder.\n* Patients with receiving treatment of malignancy.\n* Patients with high risk of thromboembolism.\n* Patients with history of shock or hypersensitivity to GB-0998.\n* Patients with hereditary fructose intolerance or IgA deficiency.\n* Patients with pregnant or probably pregnant.'}, 'identificationModule': {'nctId': 'NCT02032095', 'briefTitle': 'The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Japan Blood Products Organization'}, 'officialTitle': 'The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.', 'orgStudyIdInfo': {'id': 'B211-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GB-0998', 'interventionNames': ['Drug: GB-0998']}], 'interventions': [{'name': 'GB-0998', 'type': 'DRUG', 'otherNames': ['Intravenous immunoglobulin (Venoglobulin IH)'], 'armGroupLabels': ['GB-0998']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Japan Blood Products Organization', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Blood Products Organization', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}