{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T20:12:57Z","timestamp":1792872777730,"version":"4.5.0"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","license":[{"start":{"date-parts":[[2024,7,20]],"date-time":"2024-07-20T00:00:00Z","timestamp":1721433600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Astellas Pharma Global Development Inc."},{"name":"Kyowa Kirin Co., Ltd."}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n            <jats:title>Background.<\/jats:title>\n            <jats:p>Focal segmental glomerulosclerosis (FSGS) is a common cause of end-stage kidney disease and frequently recurs after kidney transplantation. Recurrent FSGS (rFSGS) is associated with poor allograft and patient outcomes. Bleselumab, a fully human immunoglobulin G4 anti-CD40 antagonistic monoclonal antibody, disrupts CD40\u2212related processes in FSGS, potentially preventing rFSGS.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods.<\/jats:title>\n            <jats:p>A phase 2a, randomized, multicenter, open-label study of adult recipients (aged \u226518 y) of a living or deceased donor kidney transplant with a history of biopsy-proven primary FSGS. The study assessed the efficacy of bleselumab combined with tacrolimus and corticosteroids as maintenance immunosuppression in the prevention of rFSGS &gt;12 mo posttransplantation, versus standard of care (SOC) comprising tacrolimus, mycophenolate mofetil, and corticosteroids. All patients received basiliximab induction. The primary endpoint was rFSGS, defined as proteinuria (protein-creatinine ratio \u22653.0\u2009g\/g) with death, graft loss, or loss to follow-up imputed as rFSGS, through 3 mo posttransplant.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results.<\/jats:title>\n            <jats:p>Sixty-three patients were followed for 12 mo posttransplantation. Relative decrease in rFSGS occurrence through 3 mo with bleselumab versus SOC was 40.7% (95% confidence interval, \u221289.8 to 26.8; <jats:italic toggle=\"yes\">P<\/jats:italic> = 0.37; absolute decrease 12.7% [95% confidence interval, \u221234.5 to 9.0]). Central-blinded biopsy review found relative (absolute) decreases in rFSGS of 10.9% (3.9%), 17.0% (6.2%), and 20.5% (7.5%) at 3, 6, and 12 mo posttransplant, respectively; these differences were not statistically significant. Adverse events were similar for both treatments. No deaths occurred during the study.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions.<\/jats:title>\n            <jats:p>In at-risk kidney transplant recipients, bleselumab numerically reduced proteinuria occurrence versus SOC, but no notable difference in occurrence of biopsy-proven rFSGS was observed.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/tp.0000000000004985","type":"journal-article","created":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T15:00:57Z","timestamp":1711983657000},"page":"1782-1792","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy and Safety of Bleselumab in Preventing the Recurrence of Primary Focal Segmental Glomerulosclerosis in Kidney Transplant Recipients: A Phase 2a, Randomized, Multicenter Study"],"prefix":"10.1097","volume":"108","author":[{"given":"Jun","family":"Shoji","sequence":"first","affiliation":[{"name":"Division of Transplant Nephrology, University of California San Francisco, San Francisco, CA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William C.","family":"Goggins","sequence":"additional","affiliation":[{"name":"Division of Transplant Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason R.","family":"Wellen","sequence":"additional","affiliation":[{"name":"Division of Transplantation, Department of Surgery, Washington University in St Louis, St Louis, MO."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick N.","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Section of Nephrology, Department of Medicine, University of Chicago, Chicago, IL."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olwyn","family":"Johnston","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirley S.","family":"Chang","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Erie County Medical Center, Buffalo, NY."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Solez","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicki","family":"Santos","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development Inc, Northbrook, IL."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tami J.","family":"Larson","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development Inc, Northbrook, IL."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development Inc, Northbrook, IL."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuegong","family":"Wang","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development Inc, Northbrook, IL."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,7,20]]},"reference":[{"issue":"Suppl 1","key":"R1-20250604","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1159\/000510748","article-title":"Update on recurrent focal segmental glomerulosclerosis in kidney 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