{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T14:22:29Z","timestamp":1793110949618,"version":"4.5.0"},"reference-count":24,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","license":[{"start":{"date-parts":[[2024,10,9]],"date-time":"2024-10-09T00:00:00Z","timestamp":1728432000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Kidney360"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Key Points<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>In the NefIgArd trial China cohort, 9 months of nefecon treatment led to clinically relevant preservation of kidney function over 2 years.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Durable proteinuria reduction was also observed over 2 years with 9 months of nefecon treatment.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>These results were consistent with those of the global study population and support the disease-modifying effects of nefecon.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>IgA nephropathy (IgAN), an immune-mediated kidney disease, is particularly prevalent among individuals of East Asian ancestry. Nefecon is a novel, oral, targeted-release budesonide formulation designed to inhibit galactose-deficient IgA1 formation underlying IgAN pathophysiology. We present findings in patients with IgAN from mainland China participating in the 2-year, multicenter, randomized, double-blind, phase 3 NefIgArd trial of nefecon.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients (aged 18 years and older) with primary IgAN (eGFR 35\u201390 ml\/min per 1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      , persistent proteinuria [urine protein\u2013creatinine ratio \u22650.8 g\/g or proteinuria \u22651 g\/24 hours] despite optimized renin-angiotensin system blockade) received nefecon or placebo over 9 months, followed by a 15-month follow-up phase on supportive care alone. The primary efficacy end point was time-weighted average of eGFR over 2 years.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Sixty-two patients from mainland China were included in this prespecified analysis. The primary efficacy end point was 9.6 ml\/min per 1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      (95% confidence interval, 2.0 to 19.8) in favor of nefecon versus placebo. This was consistent with (and numerically greater than) that of the global study population. Time to confirmed 30% eGFR reduction or kidney failure from baseline was substantially delayed with nefecon (patients with an event: 9%) versus placebo (30%; hazard ratio, 0.21; 95% confidence interval, 0.04 to 0.73). No deaths were reported in the China cohort. In the nefecon group, treatment-emergent serious adverse events were reported by one patient during treatment and two patients during follow-up (versus no patients and seven patients, respectively, in the placebo group). No severe infections requiring hospitalization were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Nefecon treatment for 9 months showed greater preservation of eGFR over 2 years compared with placebo. The efficacy outcomes were consistent with global study results, with a numerically greater treatment benefit observed in patients from China. Nefecon was well tolerated, with no unexpected safety signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial registry name and registration number:<\/jats:title>\n                    <jats:p>Efficacy and Safety of Nefecon in Patients With Primary IgAN, NCT03643965.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.34067\/kid.0000000583","type":"journal-article","created":{"date-parts":[[2024,10,9]],"date-time":"2024-10-09T12:14:05Z","timestamp":1728476045000},"page":"1881-1892","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":21,"title":["Efficacy and Safety of Nefecon in Patients with IgA Nephropathy from Mainland China: 2-Year NefIgArd Trial Results"],"prefix":"10.34067","volume":"5","author":[{"given":"Hong","family":"Zhang","sequence":"first","affiliation":[{"name":"Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3906-7934","authenticated-orcid":false,"given":"Richard","family":"Lafayette","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, Stanford University, Stanford, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bei","family":"Wang","sequence":"additional","affiliation":[{"name":"Everest Medicines Ltd., Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Ying","sequence":"additional","affiliation":[{"name":"Everest Medicines Ltd., Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengying","family":"Zhu","sequence":"additional","affiliation":[{"name":"Everest Medicines Ltd., Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Stone","sequence":"additional","affiliation":[{"name":"Stone Biostatistics Ltd., Crewe, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Kristensen","sequence":"additional","affiliation":[{"name":"JDK Pharmaconsulting, Espergarde, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9063-7229","authenticated-orcid":false,"given":"Jonathan","family":"Barratt","sequence":"additional","affiliation":[{"name":"The Mayer IgA Nephropathy Laboratories, Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,10,9]]},"reference":[{"issue":"25","key":"B1-20250823","doi-asserted-by":"crossref","first-page":"2402","DOI":"10.1056\/NEJMra1206793","article-title":"IgA nephropathy","volume":"368","author":"Wyatt","year":"2013","journal-title":"N Engl J Med."},{"issue":"5","key":"B2-20250823","doi-asserted-by":"crossref","first-page":"504","DOI":"10.1016\/j.semnephrol.2018.05.020","article-title":"The gut\u2013renal connection in IgA nephropathy","volume":"38","author":"Coppo","year":"2018","journal-title":"Semin Nephrol."},{"issue":"10","key":"B3-20250823","doi-asserted-by":"crossref","first-page":"1620","DOI":"10.1016\/j.ekir.2020.08.009","article-title":"Why target the gut to treat IgA nephropathy?","volume":"5","author":"Barratt","year":"2020","journal-title":"Kidney Int Rep."},{"issue":"10405","key":"B4-20250823","doi-asserted-by":"crossref","first-page":"859","DOI":"10.1016\/S0140-6736(23)01554-4","article-title":"Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial","volume":"402","author":"Lafayette","year":"2023","journal-title":"Lancet."},{"issue":"4S","key":"B5-20250823","first-page":"S1","article-title":"KDIGO 2021 clinical practice guideline for the management of glomerular diseases","volume":"100","year":"2021","journal-title":"Kidney Int."},{"issue":"5","key":"B6-20250823","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1007\/s00281-021-00884-7","article-title":"Is IgA nephropathy the same disease in different parts of the world?","volume":"43","author":"Zhang","year":"2021","journal-title":"Semin Immunopathol."},{"issue":"3","key":"B7-20250823","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1159\/000225563","article-title":"Immunoglobulin A nephropathy in China: progress and challenges","volume":"30","author":"Cai","year":"2009","journal-title":"Am J Nephrol."},{"issue":"3","key":"B8-20250823","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1111\/j.1440-1797.2007.00898.x","article-title":"Natural history of immunoglobulin A nephropathy and predictive factors of prognosis: a long-term follow up of 204 cases in China","volume":"13","author":"Lv","year":"2008","journal-title":"Nephrology (Carlton)."},{"issue":"1","key":"B9-20250823","doi-asserted-by":"crossref","first-page":"S45","DOI":"10.1016\/j.jval.2021.11.209","article-title":"POSA64 the life-long economic burden of immunoglobulin A nephropathy (IGAN) in China","volume":"25","author":"Xiao","year":"2022","journal-title":"Value in Health."},{"issue":"1","key":"B10-20250823","doi-asserted-by":"crossref","first-page":"S126","DOI":"10.1016\/j.jval.2021.11.605","article-title":"POSA204 disease burden of Iga nephropathy in China","volume":"25","author":"Du","year":"2022","journal-title":"Value in Health."},{"issue":"6","key":"B11-20250823","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1038\/ki.2009.499","article-title":"Long-term study of mycophenolate mofetil treatment in IgA nephropathy","volume":"77","author":"Tang","year":"2010","journal-title":"Kidney Int."},{"issue":"9","key":"B12-20250823","doi-asserted-by":"crossref","first-page":"1730","DOI":"10.1016\/j.ekir.2023.06.010","article-title":"Challenges in IgA nephropathy management: an era of complement inhibition","volume":"8","author":"Tesar","year":"2023","journal-title":"Kidney Int Rep."},{"issue":"19","key":"B13-20250823","doi-asserted-by":"crossref","first-page":"1888","DOI":"10.1001\/jama.2022.5368","article-title":"Effect of oral methylprednisolone on decline in kidney function or kidney failure in patients with IgA nephropathy: the TESTING randomized clinical trial","volume":"327","author":"Lv","year":"2022","journal-title":"JAMA."},{"issue":"10","key":"B14-20250823","doi-asserted-by":"crossref","first-page":"1584","DOI":"10.2215\/CJN.04370418","article-title":"Insights into the role of mucosal immunity in IgA nephropathy","volume":"13","author":"Zhang","year":"2018","journal-title":"Clin J Am Soc Nephrol."},{"issue":"2","key":"B15-20250823","doi-asserted-by":"crossref","first-page":"802","DOI":"10.1111\/j.1523-1755.2005.00460.x","article-title":"Mycophenolate mofetil alleviates persistent proteinuria in IgA nephropathy","volume":"68","author":"Tang","year":"2005","journal-title":"Kidney Int."},{"issue":"6","key":"B16-20250823","doi-asserted-by":"crossref","first-page":"788","DOI":"10.1053\/j.ajkd.2016.11.027","article-title":"Mycophenolate mofetil combined with prednisone versus full-dose prednisone in IgA nephropathy with active proliferative lesions: a randomized controlled trial","volume":"69","author":"Hou","year":"2017","journal-title":"Am J Kidney Dis."},{"issue":"2","key":"B17-20250823","doi-asserted-by":"crossref","first-page":"e2254054","DOI":"10.1001\/jamanetworkopen.2022.54054","article-title":"Effectiveness of mycophenolate mofetil among patients with progressive IgA nephropathy: a randomized clinical trial","volume":"6","author":"Hou","year":"2023","journal-title":"JAMA Netw Open."},{"issue":"1","key":"B18-20250823","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1053\/j.ajkd.2019.01.026","article-title":"Effects of hydroxychloroquine on proteinuria in IgA nephropathy: a randomized controlled trial","volume":"74","author":"Liu","year":"2019","journal-title":"Am J Kidney Dis."},{"issue":"2","key":"B19-20250823","doi-asserted-by":"crossref","first-page":"391","DOI":"10.1016\/j.kint.2022.09.017","article-title":"Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy","volume":"103","author":"Barratt","year":"2023","journal-title":"Kidney Int."},{"issue":"5","key":"B20-20250823","doi-asserted-by":"crossref","first-page":"1017","DOI":"10.1038\/ki.2013.210","article-title":"Individuals of Pacific Asian origin with IgA nephropathy have an increased risk of progression to end-stage renal disease","volume":"84","author":"Barbour","year":"2013","journal-title":"Kidney Int."},{"issue":"11","key":"B21-20250823","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1038\/ng.3118","article-title":"Discovery of new risk loci for IgA nephropathy implicates genes involved in immunity against intestinal pathogens","volume":"46","author":"Kiryluk","year":"2014","journal-title":"Nat Genet."},{"issue":"7","key":"B22-20250823","doi-asserted-by":"crossref","first-page":"1091","DOI":"10.1038\/s41588-023-01422-x","article-title":"Genome-wide association analyses define pathogenic signaling pathways and prioritize drug targets for IgA nephropathy","volume":"55","author":"Kiryluk","year":"2023","journal-title":"Nat Genet."},{"issue":"23","key":"B23-20250823","doi-asserted-by":"crossref","first-page":"2225","DOI":"10.1056\/NEJMoa1415463","article-title":"STOP-IgAN Investigators: intensive supportive care plus immunosuppression in IgA nephropathy","volume":"373","author":"Rauen","year":"2015","journal-title":"N Engl J Med."},{"issue":"2","key":"B24-20250823","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1016\/j.kint.2023.11.003","article-title":"Targeted-release budesonide modifies key pathogenic biomarkers in immunoglobulin A nephropathy: insights from the NEFIGAN trial","volume":"105","author":"Wimbury","year":"2024","journal-title":"Kidney Int."}],"container-title":["Kidney360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.34067\/KID.0000000583","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T19:59:19Z","timestamp":1786478359000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.34067\/KID.0000000583"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,9]]},"references-count":24,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024]]}},"URL":"https:\/\/doi.org\/10.34067\/kid.0000000583","relation":{},"ISSN":["2641-7650"],"issn-type":[{"value":"2641-7650","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,9]]},"assertion":[{"value":"2024-06-06","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-13","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}