Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00586716
Status:
TERMINATED
Last Update Posted:
2017-01-09
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PBaron@llu.edu', 'phone': '909-558-6792', 'title': 'Dr. Pedro Baron', 'organization': 'Loma Linda University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'A limitation to this study is early termination leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'description': 'Serious and non-serious adverse events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 Intravenous Immune Globulin', 'description': 'Group 1 with Intravenous immune globulin with no living donor', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 Intravenous Immune Globulin', 'description': 'Group 2 intravenous immune globulin WITH living donor', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Elimination of Donor Specific Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Immune Globulin', 'description': 'Intravenous immune globulin for patients who have living donors with positive crossmatch results'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated and no data for the outcome was collected/analyzed because it could not be located.'}, {'type': 'SECONDARY', 'title': 'Negative B and T Cell Crossmatch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Intravenous Immune Globulin', 'description': 'Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list\n\nintravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments'}, {'id': 'OG001', 'title': 'Group 2 Intravenous Immune Globulin', 'description': 'Intravenous immune globulin for patients who have living donors with positive crossmatch results.\n\nintravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments'}], 'timeFrame': '1year', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated and no data for the outcome was collected/analyzed because it could not be located.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 Intravenous Immune Globulin no Living Donor', 'description': 'Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list\n\nintravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments'}, {'id': 'FG001', 'title': 'Group 2 Intravenous Immune Globulin With Living Donor', 'description': 'Patients who have living donors with positive crossmatch results.\n\nintravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IVIG no Living Donor', 'description': 'Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list'}, {'id': 'BG001', 'title': 'IVIG With Living Donor', 'description': 'Intravenous immune globulin for patients who have living donors with positive crossmatch results.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-28', 'studyFirstPostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elimination of Donor Specific Antibodies', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Negative B and T Cell Crossmatch', 'timeFrame': '1year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.', 'detailedDescription': 'The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 years of age or older\n* diagnosed with end stage renal disease\n* currently receiving either hemodialysis or peritoneal dialysis\n* active on the kidney or kidney/pancreas transplant list\n* medical clearance of the kidney donor if live related transplant\n* elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list\n\nExclusion Criteria:\n\n* received IVIG within 6 months prior to enrollment\n* HIV positive\n* Positive Hepatitis Be-antigen and/or hepatitis B viral DNA\n* Selective IgA deficiency or known antibodies to IgA\n* Allergy to human immune globulin\n* Pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT00586716', 'briefTitle': 'Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA', 'orgStudyIdInfo': {'id': '54298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1 intravenous immune globulin', 'description': 'Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list', 'interventionNames': ['Drug: intravenous immune globulin']}, {'type': 'OTHER', 'label': 'Group 2 intravenous immune globulin', 'description': 'Intravenous immune globulin for patients who have living donors with positive crossmatch results.', 'interventionNames': ['Drug: intravenous immune globulin']}], 'interventions': [{'name': 'intravenous immune globulin', 'type': 'DRUG', 'description': '0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments', 'armGroupLabels': ['Group 1 intravenous immune globulin', 'Group 2 intravenous immune globulin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Okechukwu Ojogho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda Universtiy Adventist Health Sciences Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}