{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T09:23:36Z","timestamp":1787390616791,"version":"build-2736575974"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T00:00:00Z","timestamp":1783468800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015303","name":"Otsuka Pharmaceutical Development and Commercialization","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015303","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,31]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Immunoglobulin A (IgA) nephropathy is a progressive immune-mediated chronic kidney disease with a high prevalence and disease burden in East Asia, including China. In a prespecified interim analysis (IA) of the global phase 3 VISIONARY trial, treatment with sibeprenlimab led to significant placebo-adjusted reduction in 24-hour urine protein-to-creatinine ratio (uPCR-24h) of 51.2% (P &amp;lt;\u00a0.0001) at 9 months. Here, we report the interim efficacy and safety findings for sibeprenlimab for patients with IgA nephropathy enrolled from mainland China as part of the main global population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients (N = 102) were randomized 1:1 to receive sibeprenlimab 400 mg or placebo subcutaneously Q4W for 26 doses. Patients who completed the 9-month uPCR-24h assessment were included. The primary endpoint was change in uPCR-24h from baseline at 9 months. The key secondary endpoint of annualized estimated glomerular filtration rate slope over 24 months will be reported at trial completion. Other secondary and exploratory endpoints included spot urine protein-to-creatinine ratio (spot uPCR), proteinuria remission, haematuria resolution, reduction in biomarker levels [including galactose-deficient IgA1 (Gd-IgA1) and a proliferation-inducing ligand (APRIL)], and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>By the China IA data cutoff (January 2025), 42 patients from mainland China completed the 9-month uPCR-24h assessment (sibeprenlimab, n = 25; placebo, n = 17) and were included in the efficacy analysis. At 9 months, a reduction from baseline in uPCR-24h of 63.1% was observed in sibeprenlimab-treated patients versus a decrease of 3.1% in the placebo group, corresponding to a placebo-adjusted reduction of 61.9% (95% confidence interval 43.2%\u201374.5%). Spot uPCR declined by week 4 and was sustained through month 12. Sibeprenlimab reduced Gd-IgA1 (67.3%) and suppressed APRIL levels (97.7%) from baseline at week 48. The incidence of treatment-emergent adverse events was similar between treatment groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Interim efficacy and safety results for the mainland China cohort were consistent with the IA of the global cohort of the VISIONARY trial (ClinicalTrials.gov: NCT05248646).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ckj\/sfag222","type":"journal-article","created":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T11:49:37Z","timestamp":1783511377000},"source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of sibeprenlimab in IgA nephropathy: interim analysis of the China cohort in the phase 3 VISIONARY trial"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9855-4068","authenticated-orcid":false,"given":"Hong","family":"Zhang","sequence":"first","affiliation":[{"name":"Peking University First Hospital, Renal Division , Beijing ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0963-6270","authenticated-orcid":false,"given":"Adrian","family":"Liew","sequence":"additional","affiliation":[{"name":"Mount Elizabeth Novena Hospital, The Kidney and Transplant Practice ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muh Geot","family":"Wong","sequence":"additional","affiliation":[{"name":"Concord Repatriation General Hospital, Department of Renal Medicine , Concord ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deqiong","family":"Xie","sequence":"additional","affiliation":[{"name":"Second People\u2019s Hospital of Yibin, Department of Nephrology , Yibin ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caili","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Baotou Medical University, Renal Division, Department of Medicine , Baotou ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wanhong","family":"Lu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Xi\u2019an Jiaotong University, Department of Nephrology , Xian ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guisen","family":"Li","sequence":"additional","affiliation":[{"name":"Sichuan Provincial People\u2019s Hospital, Department of Nephrology , Chengdu ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xia","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development and Commercialization, Inc. , Princeton ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecile","family":"Fajardo","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development and Commercialization, Inc. , Princeton ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Hafkin","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development and Commercialization, Inc. , Princeton ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jicheng","family":"Lv","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Renal Division , Beijing ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,7,8]]},"reference":[{"key":"2026082204363457700_bib1","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1038\/s41581-024-00885-3","article-title":"The pathogenesis of IgA nephropathy and implications for treatment","volume":"21","author":"Cheung","year":"2025","journal-title":"Nat Rev Nephrol"},{"key":"2026082204363457700_bib2","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1056\/NEJMoa2512133","article-title":"Sibeprenlimab in IgA nephropathy\u2014interim analysis of a phase 3 trial","volume":"394","author":"VISIONARY Trial Investigators Group","year":"2026","journal-title":"N Engl J Med"},{"key":"2026082204363457700_bib3","doi-asserted-by":"publisher","first-page":"414","DOI":"10.1093\/ndt\/gfq665","article-title":"The incidence of primary glomerulonephritis worldwide: a systematic review of the 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