Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-05 @ 5:26 PM
Study NCT ID:
NCT00176059
Status:
COMPLETED
Last Update Posted:
2007-05-10
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant 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'}, {'id': 'D016030', 'term': 'Kidney Transplantation'}], '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': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-08', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2007-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient survival', 'timeFrame': '1 year / 3 years / 5 years posttransplant'}, {'measure': 'graft survival', 'timeFrame': '1 year / 3 years / 5 years posttransplant'}, {'measure': 'acute rejection', 'timeFrame': '1 year'}, {'measure': 'chronic allograft nephropathy', 'timeFrame': '3 years / 5 years posttransplant'}], 'secondaryOutcomes': [{'measure': 'graft function', 'timeFrame': '1 year / 3 years / 5 years'}, {'measure': 'infectious complications', 'timeFrame': '1 year'}, {'measure': 'immunoglobulin levels', 'timeFrame': '1 year'}, {'measure': 'regulatory autoantibody levels', 'timeFrame': '1 year / 3 years / 5 years'}, {'measure': 'Th1 and Th2 responses', 'timeFrame': '1 year / 3 years'}, {'measure': 'B-cell/monocyte responses', 'timeFrame': '1 year / 3 years'}, {'measure': 'Expression of adhesion molecules, costimulatory molecules and cytokine receptors', 'timeFrame': '1 year / 3 years'}, {'measure': 'proteinuria (quantitative assessment)', 'timeFrame': '1 year / 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunoglobulins, intravenous', 'kidney transplantation', 'acute rejection', 'chronic rejection', 'regulatory autoantibodies', 'Th1', 'Th2', 'B Cell', 'Monokines', 'Cytokine promoter gene polymorphisms'], 'conditions': ['Renal Failure, Chronic', 'Renal Transplantation']}, 'referencesModule': {'references': [{'pmid': '15919463', 'type': 'BACKGROUND', 'citation': 'Weimer R, Susal C, Yildiz S, Streller S, Pelzl S, Staak A, Renner F, Dietrich H, Daniel V, Feuring E, Kamali-Ernst S, Ernst W, Padberg W, Opelz G. sCD30 and neopterin as risk factors of chronic renal transplant rejection: impact of cyclosporine A, tacrolimus, and mycophenolate mofetil. Transplant Proc. 2005 May;37(4):1776-8. doi: 10.1016/j.transproceed.2005.02.088.'}, {'pmid': '9665014', 'type': 'BACKGROUND', 'citation': 'Weimer R, Zipperle S, Daniel V, Carl S, Staehler G, Opelz G. Superior 3-year kidney graft function in patients with impaired pretransplant Th2 responses. Transpl Int. 1998;11 Suppl 1:S350-6. doi: 10.1007/s001470050496.'}, {'pmid': '8970616', 'type': 'BACKGROUND', 'citation': 'Weimer R, Zipperle S, Daniel V, Carl S, Staehler G, Opelz G. Pretransplant CD4 helper function and interleukin 10 response predict risk of acute kidney graft rejection. Transplantation. 1996 Dec 15;62(11):1606-14. doi: 10.1097/00007890-199612150-00014.'}, {'pmid': '10798750', 'type': 'BACKGROUND', 'citation': 'Susal C, Dohler B, Opelz G. Graft-protective role of high pretransplantation IgA-anti-Fab autoantibodies: confirmatory evidence obtained in more than 4000 kidney transplants. The Collaborative Transplant Study. Transplantation. 2000 Apr 15;69(7):1337-40. doi: 10.1097/00007890-200004150-00021.'}, {'pmid': '11271315', 'type': 'BACKGROUND', 'citation': 'Susal C, Dorr C, Groth J, May G, Opelz G. Pretransplant serum IgA concentration and IgA-anti-Fab autoantibody activity as prognostic indicators of kidney graft survival. Transpl Int. 1994;7 Suppl 1:S586-9. doi: 10.1111/j.1432-2277.1994.tb01450.x.'}, {'pmid': '7878810', 'type': 'BACKGROUND', 'citation': 'Susal C, Wiesel M, Staehler G, Groth J, May G, Opelz G. Excellent kidney graft survival in patients with high pretransplant serum IgA concentrations and IgA-anti-Fab autoantibody activity. Transplant Proc. 1995 Feb;27(1):1072-4. No abstract available.'}, {'pmid': '2269482', 'type': 'BACKGROUND', 'citation': 'Susal C, Guo ZG, Terness P, Opelz G. Role of anti-IgG autoantibodies in kidney transplantation. Immunol Lett. 1990 Nov;26(2):121-5. doi: 10.1016/0165-2478(90)90133-b.'}, {'pmid': '9123373', 'type': 'BACKGROUND', 'citation': 'Susal C, Wiesel M, Schonemann C, Groth J, Carl S, Staehler G, May G, Opelz G. Presensitization and HLA match influence the predictive power of pretransplant serum IgA and IgA-anti-Fab autoantibodies in kidney graft recipients. Transplant Proc. 1997 Feb-Mar;29(1-2):1444-6. doi: 10.1016/s0041-1345(96)00551-9. No abstract available.'}, {'pmid': '8958291', 'type': 'BACKGROUND', 'citation': 'Susal C, Kropelin M, Groth J, Wiesel M, May G, Carl S, Staehler G, Opelz G. Protective effect of autoantibodies against the hinge region of human IgG in kidney graft recipients. Transplantation. 1996 Nov 27;62(10):1534-6. doi: 10.1097/00007890-199611270-00032. No abstract available.'}, {'pmid': '7482869', 'type': 'BACKGROUND', 'citation': 'Susal C, Kropelin M, Wiesel M, Staehler G, Groth J, May G, Opelz G. Pretransplant IgA-anti-hinge and IgA-anti-Fab autoantibody activity is associated with good kidney graft survival. Transplant Proc. 1995 Oct;27(5):2663-5. No abstract available.'}, {'pmid': '12030431', 'type': 'BACKGROUND', 'citation': 'Terness PI, Navolan D, Dufter C, Welschof M, Opelz G. Immunosuppressive anti-immunoglobulin autoantibodies: specificity, gene structure and function in health and disease. Cell Mol Biol (Noisy-le-grand). 2002 May;48(3):271-8.'}, {'pmid': '9123359', 'type': 'BACKGROUND', 'citation': "Terness P, Navolan D, Kohl I, Siedler F, Moroder L, Dufter C, Welschof M, Schneider F, Drugarin D, Opelz G. Role of idiotype-independent anti-IgG autoantibodies in human kidney transplantation: natural anti-F(ab')2 antibodies recognize an IgG1 hinge region epitope. Transplant Proc. 1997 Feb-Mar;29(1-2):1412-4. doi: 10.1016/s0041-1345(96)00614-8. No abstract available."}, {'pmid': '8892664', 'type': 'BACKGROUND', 'citation': "Terness P, Navolan D, Moroder L, Siedler F, Weyher E, Kohl I, Dufter C, Welschof M, Drugarin D, Schneider F, Opelz G. A natural IgA-anti-F(ab')2gamma autoantibody occurring in healthy individuals and kidney graft recipients recognizes an IgG1 hinge region epitope. J Immunol. 1996 Nov 1;157(9):4251-7."}, {'pmid': '8116041', 'type': 'BACKGROUND', 'citation': 'Tyan DB, Li VA, Czer L, Trento A, Jordan SC. Intravenous immunoglobulin suppression of HLA alloantibody in highly sensitized transplant candidates and transplantation with a histoincompatible organ. Transplantation. 1994 Feb 27;57(4):553-62.'}, {'pmid': '2568859', 'type': 'BACKGROUND', 'citation': 'Weimer R, Schweighoffer T, Schimpf K, Opelz G. Helper and suppressor T-cell function in HIV-infected hemophilia patients. Blood. 1989 Jul;74(1):298-302.'}, {'pmid': '1824617', 'type': 'BACKGROUND', 'citation': 'Weimer R, Daniel V, Zimmermann R, Schimpf K, Opelz G. Autoantibodies against CD4 cells are associated with CD4 helper defects in human immunodeficiency virus-infected patients. Blood. 1991 Jan 1;77(1):133-40.'}, {'pmid': '17175311', 'type': 'RESULT', 'citation': 'Staak A, Renner F, Suesal C, Dietrich H, Rainer L, Kamali-Ernst S, Ernst W, Padberg W, Opelz G, Weimer R. Immunoglobulin induction therapy in renal transplant recipients: Effects on immunoglobulin and regulatory antibody levels. Transplant Proc. 2006 Dec;38(10):3483-5. doi: 10.1016/j.transproceed.2006.10.041.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy.\n\nFurthermore clinical endpoints (patient and graft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to three years posttransplant will be analyzed.', 'detailedDescription': "Intravenous immunoglobulin (IVIG) preparations are known to be effective in the treatment of various autoimmune and inflammatory disorders due to their immunomodulatory and antiinflammatory properties. It has been demonstrated that IVIG is effective in the treatment of acute vascular rejection and steroid resistant cellular rejection. Furthermore, IVIG has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized patients so that successful cadaveric or living renal transplantation could be performed.\n\nThe aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy on Th1, Th2 and B-cell/monocyte responses, expression of adhesion molecules, costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies (anti-F(ab)-, anti-F(ab')2G-, anti-hinge autoantibodies). These autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss.\n\nFurthermore, clinical endpoints (patient and gaft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to 3 years will be analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* renal transplant recipients of the Giessen renal transplant unit\n* cadaveric and living renal transplants\n* first and retransplants\n\nExclusion Criteria:\n\n* Contraindications against blood-taking (anaemia with hemoglobin \\< 9,5 g/l, hypotension)\n* intravenous immunoglobulin therapy in the last half year before study entry\n* Hyperimmunoglobulin therapy for severe CMV infection\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00176059', 'briefTitle': 'Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Immunoglobulin Induction Therapy in Renal Transplant Recipients on Tacrolimus/Azathioprine or Tacrolimus/MMF: Effects on Th1, Th2, B Cell-/Monokine Responses and Immunoregulatory Autoantibody Levels', 'orgStudyIdInfo': {'id': 'NTx-Ig-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intravenous immunoglobulins (IVIG)', 'type': 'DRUG'}, {'name': 'kidney transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giessen', 'country': 'Germany', 'facility': 'Department of Internal Medicine, University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Rolf Weimer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, University of Giessen, Giessen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heidelberg University', 'class': 'OTHER'}, {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'Aventis Pharmaceuticals', 'class': 'INDUSTRY'}]}}}