Fadi Fakhouri, MD, PhD, is a professor of nephrology at CHUV Lausanne, Switzerland.

Fadi Fakhouri, MD, PhD

Counting down the biggest news from major medical meetings, it's the HCPLive Five!

HCPLive Five at European Renal Association (ERA) Congress 2025

European Renal Association (ERA) Congress

 is a medical conference bringing together world-renowned experts, researchers, and practitioners in nephrology. ERA Congress 2025 was hosted in Vienna, Austria, and saw more than 10,000 participants from  91 countries around the world, with a record 2835 abstract submissions. This year’s conference was centered around the theme “Game Changers in Nephrology” with the slogan “Beyond Nephrology,” boasting a comprehensive and innovative program exploring the latest advancements and transformative ideas in nephrology.

As part of HCPLive’s on-site coverage, the editorial team conducted expert interviews and reported on timely topics across therapeutic advances, pipeline updates, new renal clinical trial data, and more. In this edition of the HCPLive Five, the team highlights key conversations on pegcetacoplan in 

 and idiopathic immune-complex membranoproliferative glomerulonephritis (IC-MPGN), a trio of 

 drugs in clinical development, and the potential benefits of simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) in patients with 

Pegcetacoplan Sustains Proteinuria Reductions in C3G, IC-MPGN at 52 Weeks

Extended data from the phase 3 VALIANT trial were presented at ERA 2025 and support the sustained efficacy and safety of pegcetacoplan (Empaveli) in patients with C3G or IC-MPGN, including adolescents and adults with native or transplanted kidneys. The 52-week results show continued proteinuria reduction and eGFR stabilization in both treatment-naïve and crossover groups, reinforcing 26-week data presented at the American Society of Nephrology’s 2024 Scientific Sessions.

In this on-site interview at the meeting, Fadi Fakhouri, MD, PhD, co-lead principal investigator for the VALIANT study and a professor of nephrology at CHUV Lausanne, Switzerland, describes pegcetacoplan’s long-term potential in C3G and IC-MPGN and how the data presented at ERA could shift treatment strategies.

Understanding Zigakibart's Potential in IgA Nephropathy, with Jonathan Barratt, MD, PhD

100-week data from the phase 1/2 ADU-CL-19 trial presented at ERA suggest zigakibart, an APRIL inhibitor under development by Novartis, offers durable reductions in proteinuria and maintains a favorable safety profile in patients with IgAN. In the study, patients experienced a mean 60% reduction in proteinuria from baseline, with 55% achieving proteinuria below 500 mg and 31% below 300 mg, as described by Jonathan Barratt, MD, PhD, the Mayer Professor of Renal Medicine at the University of Leicester, in this interview. Additionally, serum IgA and pathogenic Gd-IgA1 levels dropped by 74%, building on earlier 52-week data showing reductions in IgA, IgM, and IgG of 67%, 78%, and 35%, respectively.

Kidney Compass: CONFIDENCE Trial at ERA 2025, with Rajiv Agarwal, MD, MS

Simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) in patients with CKD and type 2 diabetes was well-tolerated and resulted in significantly greater reductions in urinary albumin-to-creatinine ratio (UACR) than either agent alone, according to results from the CONFIDENCE trial. During ERA, Kidney Compass host Brendon Neuen, MBBS, PhD, a senior research fellow with the George Institute for Global Health and the director of the Kidney Trials Unit with Royal North Shore Hospital, held a discussion with trial investigators Rajiv Agarwal, MD, Professor Emeritus at Indiana University School of Medicine, about the study results and what they mean for CKD management landscape in real-world settings.

Phase 3 ORIGIN Sets Stage for Atacicept in IgA Nephropathy, with Richard Lafayette, MD

Just days before the ERA 2025, the nephrology community welcomed and celebrated new positive data for atacicept in IgAN in the form of topline results from the phase 3 ORIGIN trial. Announced by Vera Therapeutics on June 02, 2025, the data indicate the trial met its primary endpoint of reduction in proteinuria at week 36, with the atacicept group achieving a 46% reduction from baseline and a statistically significant 42% reduction compared to placebo at week 36.

’s coverage of ERA, we sat down with Lafayette to discuss how this latest data adds to our understanding of atacicept and its potential role in the management of IgAN if it were to receive FDA approval.

Kidney Compass: Sibeprenlimab and the VISIONARY Trial, with Vlado Perkovic, MBBS, PhD, at ERA 2025

, hosts Brendon Neuen, MBBS, PHD, and Shikha Wadhwani, MD, MS, are joined by Vlado Perkovic, MBBS, PhD, dean and scientia professor of Medicine at UNSW Sydney, as he dives into one of the meeting’s most anticipated releases—

. Less than 2 weeks prior to the presentation, Otsuka Pharmaceutical Co. announced the US Food and Drug Administration had granted priority review for their BLA and the application has been given a target action date of November 28, 2025.

These 5 represent only some of the data the 

 team covered at this year's meeting! Check out more KOL insight and our full conference coverage on our 

Videos

From new data for potential IgAN treatments to the use of combination initiation therapy for type 2 diabetes and CKD, here are 5 key updates from the annual meeting.

Extended data from the phase 3 VALIANT trial support the sustained efficacy and safety of pegcetacoplan (Empaveli) in patients with 

 or idiopathic immune-complex membranoproliferative glomerulonephritis (IC-MPGN), including adolescents and adults with native or transplanted kidneys.

62nd European Renal Association (ERA 2025) Congress

, the 52-week results show continued proteinuria reduction and eGFR stabilization in both treatment-naïve and crossover groups, reinforcing the 26-week data presented at the American Society of Nephrology’s 2024 Scientific Sessions.

“The one-year Phase 3 results are very compelling, confirming EMPAVELI’s sustained benefits across key markers of disease,” said presenting investigator Fadi Fakhouri, MD, PhD, co-lead principal investigator for the VALIANT study and a professor of nephrology at CHUV Lausanne, Switzerland. “Given the high risk of kidney failure, treatment efficacy is incredibly important to C3G and primary IC-MPGN patients, many of whom are in the prime of their lives. These data further underscore the potential of EMPAVELI to make a meaningful difference for patients.”

The trial included a 26-week randomized controlled period where 63 patients received pegcetacoplan and 61 received placebo. All patients then entered a 26-week open-label period with pegcetacoplan 1080 mg administered subcutaneously twice weekly. In total, 93.7% in the pegcetacoplan group and 90.2% in the placebo group completed the full 52-week course.

At week 52, patients treated with pegcetacoplan throughout showed durable proteinuria reductions, with a mean decrease in urine protein-to-creatinine ratio (UPCR) of 67.2% (95% CI, –75.8 to –55.4). Those who switched from placebo to pegcetacoplan during the OLP experienced comparable benefit, with a 51.3% (95% CI, –62.1 to –37.5) reduction in UPCR by week 52. 

Additionally, kidney function remained stable throughout for the continuous pegcetacoplan group (LS mean change in eGFR: –1.2 mL/min/1.73 m² at week 26, –3.7 mL/min/1.73 m² at week 52). Investigators also pointed out participants who switched from placebo to pegcetacoplan showed initial eGFR decline of –7.9 mL/min/1.73 m² at week 26 followed by stabilization during the open-label period, with a decline of –4.7 mL/min/1.73 m² observed at week 52.

Safety data suggested pegcetacoplan was generally well tolerated, with treatment-emergent adverse events (TEAEs) occurring in 77.0% of continuous treatment patients and 73.7% of crossover patients. Investigators noted TEAEs were mild or moderate, and infusion-related events decreased with continued therapy. Of note, no deaths or allograft losses were reported, according to investigators.

For more on pegcetacoplan’s long-term potential in C3G and IC-MPGN, and how these results could shift treatment strategies, check out our full interview with Fakhouri from ERA 2025.

Pegcetacoplan Sustains Proteinuria Reductions in C3G, IC-MPGN at 52 Weeks, with Fadi Fakhouri, MD, PhD

Relevant disclosures of interest for Fakhouri include Alexion, Apellis, Roche, Novartis, Vifor, and others.

Fakhouri F, Ariceta G, Bomback A, et al. Pegcetacoplan for C3G and primary (idiopathic) IC-MPGN: 52-week results from the phase 3 VALIANT trial show sustained efficacy. Presented at: 62nd European Renal Association Congress. June 04 – 07, 2025. Vienna, Austria.

Appellis Pharmaceuticals. Apellis and Sobi Announce EMPAVELI® (pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN | Apellis Pharmaceuticals, Inc. Apellis Pharmaceuticals, Inc. Published June 6, 2025. Accessed June 6, 2025. 

https://investors.apellis.com/news-releases/news-release-details/apellis-and-sobi-announce-empavelir-pegcetacoplan-showed

52-week data from the VALIANT program shed further light on the potential of pegcetacoplan in C3G and IC-MPGN.

Fadi Fakhouri, MD, PhD

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