Kidney Week

Abstract: SA-OR054

Pegcetacoplan for 76 Weeks Maintains Proteinuria Reduction and Stabilizes Kidney Function in C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Session Information

• Glomerular Diseases: Clinical Trial Results
  October 24, 2026 | Location: Mile High Ballroom 4A, Convention Center
  Abstract Time: 05:50 PM - 06:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Nester, Carla M., University of Iowa Health Care, Iowa City, Iowa, United States

Carla M. Nester, MD, MS, FASN

• Bomback, Andrew S., New York-Presbyterian/Columbia University Irving Medical Center, New York, New York, United States

Andrew S. Bomback, MD, MPH

• Ariceta Iraola, María Gema, Hospital Universitari Vall d'Hebron, Barcelona, CT, Spain

María Gema Ariceta Iraola, MD, PhD

• Delmas, Yahsou, Bordeaux University Hospital, Bordeaux, France

Yahsou Delmas, MD, PhD

• Dixon, Bradley P., University of Colorado Anschutz Medical Campus School of Medicine, Aurora, Colorado, United States

Bradley P. Dixon, MD, FASN

• Gale, Daniel P., University College London, London, England, United Kingdom

Daniel P. Gale, MD, PhD

• Greenbaum, Larry A., Emory University School of Medicine, Atlanta, Georgia, United States

Larry A. Greenbaum, MD, PhD

• Han, Seung Hyeok, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Korea (the Republic of)

Seung Hyeok Han, MD, PhD

• Isbel, Nicole, The University of Queensland, Brisbane, Queensland, Australia

Nicole Isbel, MBBS, PhD

• Licht, Christoph, The Hospital for Sick Children, Toronto, Ontario, Canada

Christoph Licht, MD, FASN

• Mastrangelo, Antonio, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Lombardy, Italy

Antonio Mastrangelo

• Mizuno, Masashi, Nagoya Daigaku Daigakuin Igakukei Kenkyuka Igakubu, Nagoya, Aichi Prefecture, Japan

Masashi Mizuno, MD, PhD

• de Holanda, Maria Izabel Neves, Hospital Federal de Bonsucesso, Rio de Janeiro, Brazil

Maria Izabel Neves de Holanda, MD, PhD

• Pickering, Matthew C., Imperial College London, London, England, United Kingdom

Matthew C. Pickering, MD, PhD

• Remuzzi, Giuseppe, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Lombardy, Italy

Giuseppe Remuzzi, MD

• Van De Kar, Nicole, Radboudumc Amalia Children's Hospital, Nijmegen, Netherlands

Nicole Van De Kar, MD, PhD

• Vivarelli, Marina, Ospedale Pediatrico Bambino Gesu IRCCS, Rome, Lazio, Italy

Marina Vivarelli, MD

• Walker, Patrick D., Arkana Laboratories, Little Rock, Arkansas, United States

Patrick D. Walker, MD, FASN

• Wallace, Dean, Royal Manchester Children's Hospital, Manchester, England, United Kingdom

Dean Wallace, MD, MBBS

• Zecher, Daniel, Krankenhaus Barmherzige Bruder Regensburg, Regensburg, BY, Germany

Daniel Zecher, MD

• Le Quintrec, Moglie, Hopital Lapeyronie, Montpellier, Occitanie, France

Moglie Le Quintrec, DrMed

• Borovitz, Yael, Schneider Children's Medical Center of Israel, Petah Tikva, Center District, Israel

Yael Borovitz, MD

• Melhem, Nabil, Evelina London Children's Hospital, London, England, United Kingdom

Nabil Melhem

• Fakhouri, Fadi, Universite de Lausanne, Lausanne, VD, Switzerland

Fadi Fakhouri, MD

Background

Pegcetacoplan (C3/C3b inhibitor) significantly reduced proteinuria, cleared C3, and stabilized estimated glomerular filtration rate (eGFR) in C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis in VALIANT (NCT05067127). We describe efficacy and safety during 76 weeks (wks) of pegcetacoplan in VALIANT and the VALE extension (NCT05809531).

Methods

VALIANT methods have been reported. Those who completed could continue pegcetacoplan in the VALE extension. Interim analyses included patients with up to 76 weeks of pegcetacoplan. Outcomes, aligned by treatment duration, were assessed in the total population (N=120) and by baseline (BL) interstitial fibrosis/tubular atrophy (IFTA): ≤25% vs. 26–50%.

Results

Pegcetacoplan led to rapid and sustained proteinuria decrease (geometric mean percent change [95% CI]: wk 76, –64.1% [–71.2, –55.2]), stable absolute eGFR (least squares [LS] mean [95% CI] change: wk 76, –1.4 [–6.6, 3.9] mL/min/1.73 m²) (Figure), and stable annualized eGFR slope (–1.4 [–4.8, 1.9] mL/min/1.73 m² per year). Pegcetacoplan substantially reduced proteinuria in both BL IFTA subgroups (geometric mean percent change [95% CI] at wk 76: IFTA ≤25% [n=94], –66.8% [–73.8, –57.9]; IFTA 26–50% [n=23], –52.6% [–68.7, –28.1]). From BL to wk 76, the LS mean [95% CI] change in eGFR was +1.7 (–3.9, 7.3) mL/min/1.73 m² in patients with IFTA ≤25% and –11.0 (–20.3, –1.6) mL/min/1.73 m² in the small subgroup with IFTA 26–50%. No new safety signals were observed.

Conclusion

Rapid, significant, and sustained proteinuria reduction and stabilized eGFR occurred with 76 wks of pegcetacoplan, with no new safety signals. The IFTA subgroup analysis highlights eGFR stabilization on pegcetacoplan may be strongest in patients with ≤25% IFTA, suggesting a benefit from early detection and targeted treatment.

Funding

• Commercial Support – Apellis Pharmaceuticals, Inc and Sobi (Swedish Orphan Biovitrum AB)