Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-05 @ 5:13 PM
Study NCT ID:
NCT02294032
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2014-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of B Cells in Kidney Allograft Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007166', 'term': 'Immunosuppressive Agents'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, and plasma or serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood collection prior to and after kidney transplantation', 'timeFrame': '1,3,6,12,18,24,36,48, and 60 months', 'description': 'Blood will be collected from kidney transplant patients prior to and after their transplant (1-, 3-, 6-, 12-, 18-, 24-, 36-, 48-, and 60- months post-transplant). We will try to better understand the role of specific B-cells after kidney transplant by using enzyme-linked immunosorbent assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'B cell count', 'timeFrame': 'Up to 60 months', 'description': 'For each patient, we will be measuring the frequency of cells from each B cell subset within the total peripheral blood mononuclear cells (PBMNCs) by MACSQuant cell counts. The distribution of B cells subsets within the total B cell pool will also be determined. Mean Fluorescence Intensity (MFI) of activation markers (CD86 and CD69) on B cells will also be compared across the samples.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bcells', 'kidney allograft dysfunction', 'antibody mediated rejection'], 'conditions': ['Kidney; Complications, Allograft', 'Transplantation Infection']}, 'referencesModule': {'references': [{'pmid': '21292814', 'type': 'BACKGROUND', 'citation': 'Seron D, Moreso F, Arias M, Campistol JM, Curto J, Hernandez D, Morales JM, Sanchez-Fructuoso A, Abraira V; Spanish Late Allograft Dysfunction Study Group. Estimation of renal allograft half-life: fact or fiction? Nephrol Dial Transplant. 2011 Sep;26(9):3013-8. doi: 10.1093/ndt/gfq788. Epub 2011 Feb 3.'}, {'pmid': '21116310', 'type': 'BACKGROUND', 'citation': 'Colvin RB, Hirohashi T, Farris AB, Minnei F, Collins AB, Smith RN. Emerging role of B cells in chronic allograft dysfunction. Kidney Int Suppl. 2010 Dec;(119):S13-7. doi: 10.1038/ki.2010.436.'}, {'pmid': '20501946', 'type': 'BACKGROUND', 'citation': 'Newell KA, Asare A, Kirk AD, Gisler TD, Bourcier K, Suthanthiran M, Burlingham WJ, Marks WH, Sanz I, Lechler RI, Hernandez-Fuentes MP, Turka LA, Seyfert-Margolis VL; Immune Tolerance Network ST507 Study Group. Identification of a B cell signature associated with renal transplant tolerance in humans. J Clin Invest. 2010 Jun;120(6):1836-47. doi: 10.1172/JCI39933. Epub 2010 May 24.'}, {'pmid': '20501943', 'type': 'BACKGROUND', 'citation': 'Sagoo P, Perucha E, Sawitzki B, Tomiuk S, Stephens DA, Miqueu P, Chapman S, Craciun L, Sergeant R, Brouard S, Rovis F, Jimenez E, Ballow A, Giral M, Rebollo-Mesa I, Le Moine A, Braudeau C, Hilton R, Gerstmayer B, Bourcier K, Sharif A, Krajewska M, Lord GM, Roberts I, Goldman M, Wood KJ, Newell K, Seyfert-Margolis V, Warrens AN, Janssen U, Volk HD, Soulillou JP, Hernandez-Fuentes MP, Lechler RI. Development of a cross-platform biomarker signature to detect renal transplant tolerance in humans. J Clin Invest. 2010 Jun;120(6):1848-61. doi: 10.1172/JCI39922. Epub 2010 May 24.'}, {'pmid': '15616206', 'type': 'BACKGROUND', 'citation': 'Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med. 2004 Dec 23;351(26):2715-29. doi: 10.1056/NEJMra033540. No abstract available.'}, {'pmid': '23414100', 'type': 'BACKGROUND', 'citation': 'Barnett AN, Hadjianastassiou VG, Mamode N. Rituximab in renal transplantation. Transpl Int. 2013 Jun;26(6):563-75. doi: 10.1111/tri.12072. Epub 2013 Feb 18.'}, {'pmid': '19686595', 'type': 'BACKGROUND', 'citation': 'Rehnberg M, Amu S, Tarkowski A, Bokarewa MI, Brisslert M. Short- and long-term effects of anti-CD20 treatment on B cell ontogeny in bone marrow of patients with rheumatoid arthritis. Arthritis Res Ther. 2009;11(4):R123. doi: 10.1186/ar2789. Epub 2009 Aug 17.'}, {'pmid': '23721026', 'type': 'BACKGROUND', 'citation': 'Everly MJ. Understanding and addressing the humoral immune response in transplant recipients. Clin Transpl. 2012:225-7. No abstract available.'}, {'pmid': '23721025', 'type': 'BACKGROUND', 'citation': 'Everly MJ. Immunosuppression regimens to address alloantibodies in transplant recipients. Clin Transpl. 2012:219-23.'}, {'pmid': '23721027', 'type': 'BACKGROUND', 'citation': 'Kannabhiran D, Everly MJ, Walker-McDermott JK, Tiongko S, Friedlander R, Putheti P, Sharma V, Dadhania D. Changes in IgG subclasses of donor specific anti-HLA antibodies following bortezomib-based therapy for antibody mediated rejection. Clin Transpl. 2012:229-35.'}, {'pmid': '22883025', 'type': 'BACKGROUND', 'citation': 'Thibault-Espitia A, Foucher Y, Danger R, Migone T, Pallier A, Castagnet S, G-Gueguen C, Devys A, C-Gautier A, Giral M, Soulillou JP, Brouard S. BAFF and BAFF-R levels are associated with risk of long-term kidney graft dysfunction and development of donor-specific antibodies. Am J Transplant. 2012 Oct;12(10):2754-62. doi: 10.1111/j.1600-6143.2012.04194.x. Epub 2012 Aug 6.'}, {'pmid': '19118513', 'type': 'BACKGROUND', 'citation': 'Xu H, He X, Liu Q, Chen Y, Zhu Y, Shi D, Zhang X. The abnormal high expression of B cell activating factor belonging to TNF superfamily (BAFF) and its potential role in kidney transplant recipients. Cell Mol Immunol. 2008 Dec;5(6):465-70. doi: 10.1038/cmi.2008.58.'}, {'pmid': '20932734', 'type': 'BACKGROUND', 'citation': 'Clatworthy MR, Espeli M, Torpey N, Smith KG. The generation and maintenance of serum alloantibody. Curr Opin Immunol. 2010 Oct;22(5):669-81. doi: 10.1016/j.coi.2010.08.018.'}, {'pmid': '20613525', 'type': 'BACKGROUND', 'citation': 'Stegall MD, Raghavaiah S, Gloor JM. The (re)emergence of B cells in organ transplantation. Curr Opin Organ Transplant. 2010 Aug;15(4):451-5. doi: 10.1097/MOT.0b013e32833b9c11.'}, {'pmid': '23750851', 'type': 'BACKGROUND', 'citation': 'Lynch RJ, Silva IA, Chen BJ, Punch JD, Cascalho M, Platt JL. Cryptic B cell response to renal transplantation. Am J Transplant. 2013 Jul;13(7):1713-23. doi: 10.1111/ajt.12308. Epub 2013 Jun 10.'}, {'pmid': '19350211', 'type': 'BACKGROUND', 'citation': 'Anolik JH, Looney RJ, Lund FE, Randall TD, Sanz I. 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Epub 2009 Jun 12.'}, {'pmid': '24004120', 'type': 'BACKGROUND', 'citation': 'Shlipak MG, Matsushita K, Arnlov J, Inker LA, Katz R, Polkinghorne KR, Rothenbacher D, Sarnak MJ, Astor BC, Coresh J, Levey AS, Gansevoort RT; CKD Prognosis Consortium. Cystatin C versus creatinine in determining risk based on kidney function. N Engl J Med. 2013 Sep 5;369(10):932-43. doi: 10.1056/NEJMoa1214234.'}, {'pmid': '20962324', 'type': 'BACKGROUND', 'citation': 'Iwata Y, Matsushita T, Horikawa M, Dilillo DJ, Yanaba K, Venturi GM, Szabolcs PM, Bernstein SH, Magro CM, Williams AD, Hall RP, St Clair EW, Tedder TF. Characterization of a rare IL-10-competent B-cell subset in humans that parallels mouse regulatory B10 cells. Blood. 2011 Jan 13;117(2):530-41. doi: 10.1182/blood-2010-07-294249. Epub 2010 Oct 20.'}, {'pmid': '22453734', 'type': 'BACKGROUND', 'citation': 'Lehnhardt A, Dunst F, van Husen M, Loos S, Oh J, Eiermann T, Koch M, Kemper MJ. Elevated serum levels of B-cell activating factor in pediatric renal transplant patients. Pediatr Nephrol. 2012 Aug;27(8):1389-95. doi: 10.1007/s00467-012-2142-8. Epub 2012 Mar 28.'}, {'pmid': '23842189', 'type': 'BACKGROUND', 'citation': 'Banham G, Prezzi D, Harford S, Taylor CJ, Hamer R, Higgins R, Bradley JA, Clatworthy MR. Elevated pretransplantation soluble BAFF is associated with an increased risk of acute antibody-mediated rejection. Transplantation. 2013 Aug 27;96(4):413-20. doi: 10.1097/TP.0b013e318298dd65.'}, {'pmid': '15189742', 'type': 'BACKGROUND', 'citation': 'Thien M, Phan TG, Gardam S, Amesbury M, Basten A, Mackay F, Brink R. Excess BAFF rescues self-reactive B cells from peripheral deletion and allows them to enter forbidden follicular and marginal zone niches. Immunity. 2004 Jun;20(6):785-98. doi: 10.1016/j.immuni.2004.05.010.'}, {'pmid': '15826826', 'type': 'BACKGROUND', 'citation': 'Woodland RT, Schmidt MR. Homeostatic proliferation of B cells. Semin Immunol. 2005 Jun;17(3):209-17. doi: 10.1016/j.smim.2005.02.006.'}, {'pmid': '12794106', 'type': 'BACKGROUND', 'citation': 'Smith SH, Cancro MP. Cutting edge: B cell receptor signals regulate BLyS receptor levels in mature B cells and their immediate progenitors. J Immunol. 2003 Jun 15;170(12):5820-3. doi: 10.4049/jimmunol.170.12.5820.'}, {'pmid': '23872289', 'type': 'BACKGROUND', 'citation': 'Kandala NB, Connock M, Grove A, Sutcliffe P, Mohiuddin S, Hartley L, Court R, Cummins E, Gordon C, Clarke A. Belimumab: a technological advance for systemic lupus erythematosus patients? Report of a systematic review and meta-analysis. BMJ Open. 2013 Jul 19;3(7):e002852. doi: 10.1136/bmjopen-2013-002852. Print 2013.'}, {'pmid': '23885457', 'type': 'BACKGROUND', 'citation': 'Vadasz Z, Toubi E. [Belimumab--the biological drug for systemic lupus erythematosus: as discussed during the American College of Rheumatology (ACR) conference - 2012]. Harefuah. 2013 May;152(5):304-6. No abstract available. Hebrew.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.', 'detailedDescription': 'The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune responses after kidney transplantation. This study aims to address two major challenges in kidney transplantation: 1. to guide physicians when immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the process of developing antibody-mediated rejection. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric and Adult patients who are on the waitlist for a kidney or liver, or are about to undergo kidney or liver transplantation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and willingness to sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF\n* Either a Kidney or Liver transplant patient: 1) on the waitlist or 2) transplanted\n* Healthy volunteer samples collected to use as the control group for statistical validity\n\nExclusion Criteria:\n\n* Inability to make all of the required long-term post-transplant visits.\n* Females who are pregnant or nursing a child\n* Liver patients with hepatitis C virus'}, 'identificationModule': {'nctId': 'NCT02294032', 'briefTitle': 'The Role of B Cells in Kidney Allograft Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'The Role of B Cells in Kidney Allograft Dysfunction', 'orgStudyIdInfo': {'id': '5140147'}, 'secondaryIdInfos': [{'id': 'GCAT 2014', 'type': 'OTHER_GRANT', 'domain': 'GCAT 2014'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney Transplant', 'description': 'Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.', 'interventionNames': ['Drug: Immunosuppressive Agents']}], 'interventions': [{'name': 'Immunosuppressive Agents', 'type': 'DRUG', 'otherNames': ['Prograf, Cellcept'], 'description': 'standard of care for patients post-transplant', 'armGroupLabels': ['Kidney Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center, Transplantation Institute', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Michael de Vera, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}