The 62nd European Renal Association (ERA 2025) Congress in Vienna is poised to deliver practice-changing advancements in nephrology, featuring seven pivotal late-breaking clinical trials that could reshape treatment approaches for chronic kidney disease, dialysis patients, and glomerular diseases.
Building on the momentum from ERA 2024, which witnessed landmark results from the FLOW trial demonstrating semaglutide's renal protective effects, this year's meeting promises equally significant developments across multiple therapeutic areas.
CONFIDENCE Trial Addresses Combination Therapy Gap
The CONFIDENCE trial, presented by Rajiv Agarwal, MD, of Indiana University, represents a critical advancement in diabetic kidney disease management. This parallel-group, double-blind, 3-arm trial enrolled 1,664 patients from the US, Europe, and Asia to assess the safety and efficacy of simultaneous initiation of empagliflozin and finerenone.
"We are now in an era of multiple highly effective therapies for diabetic kidney disease with SGLT2 inhibitors, GLP-1 receptor agonists, and finerenone, but we don't yet have a lot of direct randomized evidence about how to use these medications in combination," explained Brendon Neuen, MBBS, PhD, senior research fellow with the George Institute for Global Health.
The study randomized patients with type 2 diabetes and chronic kidney disease (eGFR greater than 30 mL/min and UACR of at least 100 mg/g) to receive finerenone plus empagliflozin, empagliflozin plus placebo, or finerenone plus placebo. The primary endpoint measures relative change from baseline urinary albumin to creatinine ratio at 180 days.
ACHIEVE Trial Tackles High-Risk Dialysis Population
The Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease (ACHIEVE) trial, to be presented by Michael Walsh, MD, PhD, of McMaster University, addresses a significant evidence gap in cardiovascular care for dialysis patients.
This multicenter, double-blind, randomized controlled trial enrolled 2,538 patients across 141 sites in North America, South America, Australia, Europe, New Zealand, and Asia. Patients were randomized to receive spironolactone 25 mg or placebo, with the primary endpoint being cardiovascular death or hospitalization for heart failure.
"There has always been very limited evidence for the use of MRAs in patients with advanced CKD, particularly those with kidney failure on dialysis, and this is important because this population is at extremely high risk of cardiovascular disease," Neuen noted. The trial seeks to determine both efficacy and safety in a population facing high risks of both cardiovascular events and adverse effects like hyperkalemia.
VISIONARY Trial Targets IgA Nephropathy Pathogenesis
The VISIONARY trial, presented by Vlado Perkovic, MBBS, PhD, of George Institute for Global Health, evaluates sibeprenlimab, a proliferation-inducing ligand (APRIL) inhibitor, in patients with IgA nephropathy.
This multicenter, randomized, double-blind, placebo-controlled trial randomized 530 patients on maximally tolerated standard-of-care therapy to receive sibeprenlimab 400 mg subcutaneously every 4 weeks compared to placebo. The primary endpoint measures relative change from baseline in urinary protein to creatinine ratio in 24-hour urine collections after 9 months of treatment.
"What is so interesting about sibeprenlimab is that it's an APRIL inhibitor, and it targets the underlying immunological basis of IgA nephropathy. That is, it reduces the production of galactose deficient IgA, which is important and central to the pathogenesis the development and progression of IgA nephropathy," Neuen explained.
Additional Late-Breaking Presentations
The congress will also feature presentations on MK-2060, a novel factor XI inhibitor for preventing arteriovenous graft thrombosis in hemodialysis patients, and analyses of empagliflozin's effects on acute kidney outcomes and eGFR dips.
An updated systematic review and meta-analysis of mineralocorticoid receptor antagonists in dialysis patients will synthesize recent evidence from trials including ACHIEVE and ALCHEMIST, providing clearer guidance on the risk-benefit profile of MRAs in end-stage kidney disease.
The meeting also includes an international target trial emulation study examining survival benefits of deceased donor kidney transplantation across different patient populations, helping refine transplant candidacy criteria.
Clinical Impact and Future Directions
These trials collectively address critical questions in nephrology practice, from optimal combination therapy strategies in diabetic kidney disease to cardiovascular protection in dialysis patients and targeted treatment of glomerular diseases.
"I think we can expect a similar theme from this year's meeting in Vienna, there's some really important trial data that are being presented," Neuen said, highlighting the potential for practice-changing science similar to last year's landmark presentations.
The results from these studies are expected to provide direct randomized evidence for clinical decision-making, addressing implementation gaps and treatment inertia while offering new therapeutic options for patients with kidney disease across the spectrum of disease severity.
