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Iptacopan in IgA Nephropathy — Final 24-Month Data

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datacite.rightshttp://purl.org/coar/access_right/c_16ec
dc.contributor.authorBarratt, Jonathan
dc.contributor.authorEren, Necmi
dc.contributor.authorKashihara, Naoki
dc.contributor.authorMaes, Bart
dc.contributor.authorRizk, Dana V.
dc.contributor.authorRovin, Brad
dc.contributor.authorTrimarchi, Hernán
dc.contributor.authorZhang, Hong
dc.contributor.authorWang, Weiming
dc.contributor.authorKocyigit, Ismail
dc.contributor.authorHao, Chuanming
dc.contributor.authorTesař, Vladimir
dc.contributor.authorTurgutalp, Kenan
dc.contributor.authorYang, Li
dc.contributor.authorXing, Guangqun
dc.contributor.authorDuro Garcia, Valter
dc.contributor.authorHyeok Han, Seung
dc.contributor.authorLu, Wanhong
dc.contributor.authorPisani, Antonio
dc.contributor.authorWeinmann-Menke, Julia
dc.contributor.authorEitner, Frank
dc.contributor.authorGuerard, Nicolas
dc.contributor.authorButylin, Dmytro
dc.contributor.authorMonaco, Luca
dc.contributor.authorScosyrev, Emil
dc.contributor.authorMagirr, Annabel
dc.contributor.authorRenfurm, Ronny
dc.contributor.authorHach, Thomas
dc.contributor.authorPerkovic, Vlado
dc.contributor.authorthe APPLAUSE-IgAN Study Group
dc.contributor.authorAroca-Martinez, Gustavo
dc.contributor.authorZuluaga, Gustavo
dc.date.accessioned2026-04-07T15:51:16Z
dc.date.available2026-04-07T15:51:16Z
dc.date.issued2026
dc.description.abstractBackground Overactivation of the alternative complement pathway contributes to IgA nephropathy and glomerular inflammation. In the 9-month interim analysis of this phase 3 trial, iptacopan, a complement factor B inhibitor, led to a significant reduction of 38.3% in the 24-hour urinary protein-to-creatinine ratio as compared with placebo and had an acceptable safety profile. Methods In this phase 3 trial, we enrolled adults who had IgA nephropathy, an estimated glomerular filtration rate (eGFR) of at least 30 ml per minute per 1.73 m2 of body-surface area, and a 24-hour urinary protein-to-creatinine ratio of 1 or higher (with protein and creatinine both measured in grams) despite supportive care. Patients were randomly assigned, in a 1:1 ratio, to receive oral iptacopan (200 mg) or placebo twice daily. The primary end point for the final analysis was the annualized total eGFR slope as estimated over a 24-month period. Secondary end points included a composite kidney-failure end point (i.e., a sustained decline in eGFR of ≥30%, a sustained eGFR of <15 ml per minute per 1.73 m2, the initiation of maintenance dialysis, receipt of kidney transplant, or death from kidney failure), assessed in a time-to-event analysis. Safety was also assessed. Results Among 477 patients included in the final analysis, 238 had been randomly assigned to iptacopan and 239 to placebo. The annualized total eGFR slope was −3.10 ml per minute per 1.73 m2 per year with iptacopan, as compared with −6.12 ml per minute per 1.73 m2 per year with placebo (difference, 3.02 ml per minute per 1.73 m2 per year; 95% confidence interval [CI], 2.02 to 4.01; adjusted P<0.001). A composite kidney-failure end-point event occurred in 21.4% of the patients in the iptacopan group, as compared with 33.5% of those in the placebo group (hazard ratio, 0.57; 95% CI, 0.40 to 0.81; adjusted P=0.003). The incidence of adverse events was 87.0% in the iptacopan group and 89.1% in the placebo group. Serious adverse events occurred in 12.2% of the patients who received iptacopan and in 11.7% of those who received placebo, and serious infections in 6.7% and 2.1%, respectively. No deaths occurred.eng
dc.format.mimetypepdf
dc.identifier.citationBarratt Jonathan, Eren Necmi, Kashihara Naoki, Maes Bart, Rizk Dana, Rovin Brad, Trimarchi Hernan, Wang Weiming, Kocyigit Ismail, Hao Chuanming, Tesar Vladimir, Turgutalp Kenan, Yang Li, Xing Guangqun, Garcia Valter, Han Seung Hyeok, Lu Wanhong, Pisani Antonio, Perkovic Vlado. (2026). Iptacopan in IgA Nephropathy — Final 24-Month Data. New England Journal of Medicine. 10.1056/NEJMoa2600743.eng
dc.identifier.doihttps://doi.org/10.1056/NEJMoa2600743
dc.identifier.issn15334406 (Electrónico)
dc.identifier.issn00284793 (Impreso)
dc.identifier.urihttps://hdl.handle.net/20.500.12442/17501
dc.identifier.urlhttps://www.nejm.org/doi/full/10.1056/NEJMoa2600743
dc.language.isoeng
dc.publisherMassachusetts Medical Societyeng
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationaleng
dc.rights.accessrightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subject.keywordsIgA nephropathyeng
dc.subject.keywordsDialysiseng
dc.subject.keywordsKidney transplantationeng
dc.titleIptacopan in IgA Nephropathy — Final 24-Month Dataeng
dc.type.driverinfo:eu-repo/semantics/article
dc.type.spaArtículo científico
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