PEGCETACOPLAN FOR 52-WEEKS MAINTAINED PROTEINURIA REDUCTION REGARDLESS OF IMMUNOSUPPRESSANT USE OR NEPHROTIC RANGE PROTEINURIA AT BASELINE: VALIANT SUBGROUP ANALYSIS

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https://storage.unitedwebnetwork.com/files/1099/6ea5972ac9fb47cc0a131be358f376d2.pdf

Abstract Title *

PEGCETACOPLAN FOR 52-WEEKS MAINTAINED PROTEINURIA REDUCTION REGARDLESS OF IMMUNOSUPPRESSANT USE OR NEPHROTIC RANGE PROTEINURIA AT BASELINE: VALIANT SUBGROUP ANALYSIS

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Co-author 1

Carla M Nester carla-nester@uiowa.edu University of Iowa, Stead Family Children’s Hospital University of Iowa, Stead Family Children’s Hospital Iowa United States *

Co-author 2

Fadi Fakhouri fadi.fakhouri@chuv.ch Lausanne University Hospital and University of Lausanne Lausanne University Hospital and University of Lausanne Lausanne Switzerland -

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Introduction

Pegcetacoplan, a targeted C3/C3b inhibitor, may prevent the deposition of C3 breakdown products, thereby reducing glomerular inflammation and kidney damage in patients with C3 glomerulopathy (C3G) or primary (idiopathic) immune-complex membranoproliferative glomerulonephritis (IC-MPGN). VALIANT (Phase 3; NCT05067127) evaluated the efficacy and safety of pegcetacoplan in adolescents (≥12 years) and adults with native or post-transplant C3G or primary IC-MPGN.

At Week 26, patients treated with pegcetacoplan demonstrated a significant reduction in proteinuria compared with placebo, along with stable estimated glomerular filtration rate (eGFR) and evidence of glomerular C3c clearance. In the subsequent 26-week open-label period (OLP), all patients received pegcetacoplan. Here, we report treatment responses in key patient subgroups, stratified by baseline proteinuria and concomitant immunosuppressant (IS) use, across both the randomized controlled period (RCP) and the OLP.

Methods

59 of 63 pegcetacoplan-to-pegcetacoplan and 55 of 61 placebo-to-pegcetacoplan patients completed OLP. Efficacy end points included changes from baseline in proteinuria and estimated glomerular filtration rate (eGFR). Treatment-emergent adverse events were recorded.

Results

Patients receiving pegcetacoplan for 52 weeks had sustained proteinuria decrease (mean [95% CI] change: week 26, –67.2% [–74.9, –57.2]; week 52, –67.2% [–75.8, –55.4]). Results were consistent with overall population regardless of IS use and baseline nephrotic proteinuria (Figure). eGFR was stable for overall pegcetacoplan-treated population (least squares mean [SE] change, mL/min/1.73 m2: week 26, –1.5 [2.2]; week 52, –3.7 [2.7]). No new safety signals were identified.

Conclusion

Proteinuria reductions and eGFR stabilization in the VALIANT RCP were maintained regardless of baseline proteinuria and IS use, confirming pegcetacoplan’s durable and consistent efficacy. eGFR was stable. The safety profile of pegcetacoplan was consistent with previous studies.

Previously presented at ASN 2025 (Journal of the American Society of Nephrology)

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