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ERA 2025 Preview: Late Breakers to Watch, with Brendon Neuen, MBBS, PhD

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Brendon Neuen, MBBS, PhD, discusses 3 late breaking clinical trials being presented at ERA 2025.

From June 4–7, the nephrology world converges in Vienna for the 2025 European Renal Association (ERA) Congress—a meeting many consider to be among the most consequential stages for kidney-related research, debate, and clinical direction.

As the burden of kidney disease grows globally, ERA continues to sharpen its role as a launchpad for data that shapes practice. Serving as evidence of this trend, last year’s meeting saw landmark results from the FLOW trial, where semaglutide 1.0 mg (Ozempic) cut kidney and cardiovascular events by 24%—the first time a GLP-1 receptor agonist showed definitive renal protection in a major outcomes trial. If that were not enough, the ALIGN trial elevated atrasentan (Vanrafia) as a targeted option for IgA nephropathy (IgAN), and APPEAR-C3G spotlighted iptacopan (Fabhalta) as a potential breakthrough for C3 glomerulopathy.

In this preview video, Brendon Neuen, MBBS, PhD, a senior research fellow with the George Institute for Global Health and director of the Kidney Trials Unit with Royal North Shore Hospital, provides an overview of the meeting. Neuen, who is a member of the HCPLive Nephrology editorial advisory board, joins us to share what’s on their radar heading into Vienna—focusing specifically on 3 trials from the meeting: CONFIDENCE, ACHIEVE, and VISIONARY.

Top 3 Trials to Watch at ERA 2025

The CONFIDENCE Trial: Efficacy/Safety of Combining Finerenone with Empagliflozin in People with Chronic Kidney Disease and Type 2 Diabetes

Presentation Time: Thursday, June 05, 2025, from 11:40 to 12:05 CEST
Presenter: Rajiv Agarwal, MD, of Indiana University
Summary:

In the last 15 years, the revelations of therapeutic benefit with SGLT2 inhibitors and introduction of finerenone, (Kerendia) have helped usher in an era where clinicians are discussing potential optimal approaches to combination therapy in chronic kidney disease and type 2 diabetes. Sponsored by Bayer, the CONFIDENCE trial is a parallel-group, double-blind, 3-arm trial launched in 2022 to assess the safety and efficacy of the simultaneous initiation of empagliflozin (Jardiance) and finerenone.

A total of 1664 patients from the US, Europe, and Asia were enrolled and patients were randomized to finerenone plus empagliflozin, empagliflozin plus placebo, or finerenone plus placebo. The primary endpoint of the study is the relative change from baseline urinary albumin to creatinine ratio at 180 days.

Spironolactone in Patients Undergoing Maintenance Dialysis: The ACHIEVE Trial

Presentation Time: Friday, June 06, 2025, from 11:51 to 12:09 CEST
Presenter: Michael Walsh, MD, PhD, of McMaster University
Summary:

Despite being a mainstay in the management of heart failure with reduced ejection fraction, the medical community lacks a clear consensus on the use of the mineralocorticoid receptor agonists (MRA) class in patients with end-stage kidney disease on dialysis—a group with a pronounced risk of adverse risk of cardiovascular outcomes.

The Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease (ACHIEVE) trial is a multicenter, double-blind, randomized controlled trial launched to understand whether use of spironolactone might decrease the risk of adverse cardiovascular outcomes in patients with end-stage kidney disease on dialysis. Launched in 2018, the trial, which enrolled 2538 patients and randomized them to spironolactone 25 mg or placebo, included patients from 141 sites across North America, South America, Australia, Europe, New Zealand, and Asia. The primary endpoint of the study is the incidence of cardiovascular death or hospitalization for heart failure.

Sibeprenlimab for Patients with IgA Nephropathy: Results From a Prespecified Interim Analysis of the Phase 3 VISIONARY Study

Presentation Time: Friday, June 06, 2025, from 11:15 to 11:33 CEST
Presenter: Vlado Perkovic, MBBS, PhD, of George Institute for Global Health
Summary:

Sponsored by Otsuka Pharmaceuticals, the VISIONARY trial was launched in 2022 to assess the efficacy and safety of sibeprenlimab, a proliferation-inducing ligand (APRIL) inhibitor, in patients with IgAN. The multicenter, randomized, double-blind, placebo-control trial randomized 530 patients on maximally tolerated standard-of-care therapy to receive sibeprenlimab 400 mg administered subcutaneous every 4 weeks compared to placebo. The primary endpoint of the trial is the relative change from baseline in urinary protein to creatinine ratio (uPCR) in 24-hour urine collections after 9 months of treatment.

On May 27, 2025, Otsuka Pharmaceuticals announced the acceptance of a Biologics License Application with the US Food and Drug Administration (FDA) for sibeprenlimab in the management of IgAN. According to the release, the FDA has assigned this submission a PDUFA date of November 28, 2025.


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