{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:40:27Z","timestamp":1792795227443,"version":"4.5.0"},"reference-count":39,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","funder":[{"DOI":"10.13039\/sphhrqbah4br","name":"Vitaeris Inc.","doi-asserted-by":"publisher","award":["unrestricted grant"],"award-info":[{"award-number":["unrestricted grant"]}],"id":[{"id":"10.13039\/sphhrqbah4br","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["JASN"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>Significance Statement<\/jats:title>\n                    <jats:p>There is no proven effective treatment for a major cause of graft failure, late antibody-mediated rejection, but IL-6, a cytokine known to promote B cell immunity, may be a promising therapeutic target. The authors describe the results of a phase 2 randomized clinical trial involving 20 patients, designed to evaluate the safety (primary endpoint) and efficacy (secondary endpoint analysis) of an anti\u2013IL-6 antibody, clazakizumab, versus placebo in late antibody-mediated rejection. Although the occurrence of serious infections and diverticulitis presented important safety signals, clazakizumab was associated with an early decrease in donor-specific antibody levels, modulated antibody-mediated rejection activity, and slowed the decline of renal function. Preliminary efficacy results suggest a potentially beneficial effect of clazakizumab and may therefore support the design of larger trials with a longer duration of follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Late antibody-mediated rejection (ABMR) is a leading cause of transplant failure. Blocking IL-6 has been proposed as a promising therapeutic strategy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a phase 2 randomized pilot trial to evaluate the safety (primary endpoint) and efficacy (secondary endpoint analysis) of the anti\u2013IL-6 antibody clazakizumab in late ABMR. The trial included 20 kidney transplant recipients with donor-specific, antibody-positive ABMR \u2265365 days post-transplantation. Patients were randomized 1:1 to receive 25 mg clazakizumab or placebo (4-weekly subcutaneous injections) for 12 weeks (part A), followed by a 40-week open-label extension (part B), during which time all participants received clazakizumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Five (25%) patients under active treatment developed serious infectious events, and two (10%) developed diverticular disease complications, leading to trial withdrawal. Those receiving clazakizumab displayed significantly decreased donor-specific antibodies and, on prolonged treatment, modulated rejection-related gene-expression patterns. In 18 patients, allograft biopsies after 51 weeks revealed a negative molecular ABMR score in seven (38.9%), disappearance of capillary C4d deposits in five (27.8%), and resolution of morphologic ABMR activity in four (22.2%). Although proteinuria remained stable, the mean eGFR decline during part A was slower with clazakizumab compared with placebo (\u22120.96; 95% confidence interval [95% CI], \u22121.96 to 0.03 versus \u22122.43; 95% CI, \u22123.40 to \u22121.46 ml\/min per 1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      per month, respectively,\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.04). During part B, the slope of eGFR decline for patients who were switched from placebo to clazakizumab improved and no longer differed significantly from patients initially allocated to clazakizumab.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although safety data indicate the need for careful patient selection and monitoring, our preliminary efficacy results suggest a potentially beneficial effect of clazakizumab on ABMR activity and progression.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1681\/asn.2020071106","type":"journal-article","created":{"date-parts":[[2020,12,23]],"date-time":"2020-12-23T13:08:31Z","timestamp":1608728911000},"page":"708-722","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":172,"title":["A Randomized Clinical Trial of Anti\u2013IL-6 Antibody Clazakizumab in Late Antibody-Mediated Kidney Transplant Rejection"],"prefix":"10.1681","volume":"32","clinical-trial-number":[{"clinical-trial-number":"nct03444103","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03744910","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03744910","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03744910","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8036-7042","authenticated-orcid":false,"given":"Konstantin","family":"Doberer","sequence":"first","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Duerr","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip F.","family":"Halloran","sequence":"additional","affiliation":[{"name":"Alberta Transplant Applied Genomics Centre, University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farsad","family":"Eskandary","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klemens","family":"Budde","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heinz","family":"Regele","sequence":"additional","affiliation":[{"name":"Department of Clinical Pathology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Reeve","sequence":"additional","affiliation":[{"name":"Alberta Transplant Applied Genomics Centre, University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Borski","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9180-620X","authenticated-orcid":false,"given":"Nicolas","family":"Kozakowski","sequence":"additional","affiliation":[{"name":"Department of Clinical Pathology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4419-6282","authenticated-orcid":false,"given":"Roman","family":"Reindl-Schwaighofer","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6988-8269","authenticated-orcid":false,"given":"Johannes","family":"Waiser","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Lachmann","sequence":"additional","affiliation":[{"name":"Centre for Tumor Medicine, Histocompatibility & Immunogenetics Laboratory, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Schranz","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christa","family":"Firbas","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakob","family":"M\u00fchlbacher","sequence":"additional","affiliation":[{"name":"Department of Surgery, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg","family":"Gelbenegger","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7976-0285","authenticated-orcid":false,"given":"Thomas","family":"Perkmann","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1301-8694","authenticated-orcid":false,"given":"Markus","family":"Wahrmann","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Kainz","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Ristl","sequence":"additional","affiliation":[{"name":"Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabian","family":"Halleck","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor","family":"Bond","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Chong","sequence":"additional","affiliation":[{"name":"Vitaeris Inc., Vancouver, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Jilma","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg A.","family":"B\u00f6hmig","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2020,12,18]]},"reference":[{"key":"B1-20240826","doi-asserted-by":"crossref","first-page":"1150","DOI":"10.1056\/NEJMra1802677","article-title":"Antibody-mediated rejection of solid-organ allografts","volume":"379","author":"Loupy","year":"2018","journal-title":"N Engl J Med"},{"key":"B2-20240826","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1111\/ajt.14600","article-title":"Review: The 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