During the 62nd European Renal Association (ERA 2025) conference, the special edition program of “Kidney Guidelines” invited Vlado Perkovic, MD, PhD, the director of the Department of Medicine at the University of New South Wales in Sydney, to deeply interpret the highly anticipated VISIONARY trial in the field of IgA nephropathy (IgAN). This 3-phase clinical trial covering 31 countries and involving 510 participants has provided breakthrough data and innovative treatment options, bringing new hope to over 150 million IgAN patients worldwide. Just before the release of the trial results, Otsuka Pharmaceutical announced that the US Food and Drug Administration (FDA) has granted priority review to the Biologics License Application (BLA) for Xibepril monoclonal antibody, with the target action date set for June 11, 2025. This further aroused industry-wide high attention.
Professor Perkovic disclosed the core data in the interview: As an innovative inhibitor targeting the proliferation-inducing ligand (APRIL), Xibepril monoclonal antibody significantly reduced the geometric mean of 24-hour urine protein-to-creatinine ratio (uPCR) by 50.2% within 9 months of treatment compared to the baseline; in contrast, the uPCR in the placebo group slightly increased by 2.1%, with a difference of 51.2% (96.5% confidence interval, 42.9% – 58.2%; P < 0.0001). “What is more noteworthy is that 98% of the participants were already receiving renin-angiotensin system inhibitors at baseline, and 39% were also using sodium-glucose cotransporter 2 (SGLT2) inhibitors.” Professor Perkovic emphasized that this means Xibepril monoclonal antibody can still bring additional significant benefits on top of the current optimized standard treatment.The scientific basis for targeting APRIL in IgAN: “APRIL plays a key role in the pathological process of IgA nephropathy, promoting abnormal IgA1 production and deposition, which in turn triggers kidney inflammation.” The VISIONARY trial precisely inhibits APRIL to block the disease progression path from the root. The trial design uses 1:1 random grouping to ensure the rigor of the results; at the same time, it includes diverse global populations to verify the universality of the therapy. “We not only focus on the short-term reduction in proteinuria, but also expect subsequent analysis to reveal its impact on long-term estimated glomerular filtration rate (eGFR) – this is the core indicator for measuring kidney function.” Professor Perkovic disclosed that the team is currently closely tracking the data on changes in patients’ renal function.
Professor Perkovic believes that the success of the VISIONARY trial may redefine the treatment standard for IgAN. “Significantly reducing proteinuria not only means symptom relief, but also indicates the possibility of delaying the progression of renal failure.” He pointed out that this study has set a new benchmark for targeted and precise nephropathy treatment and may promote the development of more innovative drugs targeting specific pathological mechanisms. At the same time, Professor Perkovic also emphasized the importance of clinical practice transformation: “We need to further verify the efficacy and safety of Xibepril monoclonal antibody in different patient groups through real-world research.” At the end of the interview, the show host, Brendon Neuen, and Shikha Wadhwani also disclosed their conflicts of interest in accordance with academic norms. Neuen was involved with multiple pharmaceutical companies such as AstraZeneca and Bayer; Wadhwani had connections with companies like Boehringer Ingelheim and Daiichi Sankyo; and Perkovic had collaborated with numerous enterprises such as Boehringer Ingelheim and AbbVie. These disclosures ensured the transparency and objectivity of the academic discussion.With the launch of the FDA’s priority review program, sibutramine has entered the countdown to clinical application. The global nephrology community is holding its breath, eagerly awaiting this breakthrough research result to effectively improve the quality of life of patients with IgAN and open up new paths for the conquest of this complex disease.
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