SOLUBLE BIOMARKERS IN IgA NEPHROPATHY: ANALYSIS OF BASELINE DATA FROM THE PHASE 2 TRIAL OF RAVULIZUMAB (SANCTUARY)

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Abstract Title *

SOLUBLE BIOMARKERS IN IgA NEPHROPATHY: ANALYSIS OF BASELINE DATA FROM THE PHASE 2 TRIAL OF RAVULIZUMAB (SANCTUARY)

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Co-author 1

Tobin J. Cammett tobin.cammett@alexion.com Alexion, AstraZeneca Rare Disease Translational Biomarker Research New Haven, CT United States -

Co-author 2

Ellen E. Millman ellen.millman@alexion.com Alexion, AstraZeneca Rare Disease Translational Biomarker Research New Haven, CT United States -

Co-author 3

Julio C. Luna Julio.Luna@alexion.com Alexion, AstraZeneca Rare Disease Translational Biomarker Research New Haven, CT United States -

Co-author 4

Kara Rice kara.rice@alexion.com Alexion, AstraZeneca Rare Disease Biostatistics Boston, MA United States -

Co-author 5

Katherine Garlo Katherine.garlo@alexion.com Alexion, AstraZeneca Rare Disease Clinical development Boston, MA United States -

Co-author 6

Andreas Kateifides andreas.kateifides@alexion.com Alexion, AstraZeneca Rare Disease Clinical development Boston, MA United States -

Co-author 7

Stephen Nolan stephen.nolan@alexion.com Alexion, AstraZeneca Rare Disease Clinical development Dublin Ireland -

Co-author 8

Cory Williams cory.williams@alexion.com Alexion, AstraZeneca Rare Disease Clinical development New Haven, CT United States -

Co-author 9

Richard A. Lafayette czar@stanford.edu Stanford University Medical Center Stanford Glomerular Disease Center Stanford, CA United States -

Co-author 10

Jonathan Barratt jb81@leicester.ac.uk University of Leicester Department of Cardiovascular Sciences Leicester United Kingdom * -

Co-author 11

Youssef M.K. Farag Youssef.farag@alexion.com Alexion, AstraZeneca Rare Disease Clinical development Boston, MA United States -

Co-author 12

Co-author 13

Co-author 14

Co-author 15

Introduction

In IgA nephropathy (IgAN), immune complex formation and deposition leads to complement activation, culminating in complement terminal pathway-mediated inflammation and kidney damage. Validated soluble biomarkers of disease activity and pathophysiology are needed in IgAN. This analysis aimed to characterize biomarkers using baseline data from the Phase 2 trial (NCT04564339) of ravulizumab (RAV) (a complement C5 inhibitor) and from healthy adult normal donors (ND).

Methods

Soluble biomarker levels in 60 patients (pts) with IgAN at baseline in SANCTUARY and from a validation cohort of up to 25 ND were compared. Biomarkers were measured from spot urine samples: sC5b-9 and factor Ba (complement pathway products), CD163 (macrophage renal infiltration marker), KIM-1 (specific marker of renal proximal tubule injury), and NGAL (marker of renal tubule injury). A stringent sample collection protocol was implemented for all samples and immunoassays were developed and validated to FDA guidance (Bioanalytical Method Validation, 2018). Biomarkers were normalized to urine creatinine (Cr).

Results

Baseline levels of 4 of 5 urine biomarkers were significantly elevated in pts with IgAN vs ND: sC5b-9/Cr, Ba/Cr, CD163/Cr, and KIM-1/Cr (p<0.0001 for all) (Table). These 4 biomarkers were also elevated above the upper limit of normal (observed mean for ND + 2 SD) in >50% of pts with IgAN, at baseline: sC5b-9 elevated in 93% of pts, CD163 in 82%, Ba in 65%, and KIM-1 in 62%.

Conclusion

Soluble urine biomarkers of complement activation, inflammation, and proximal tubule injury were detected at significantly higher levels in this cohort of pts with IgAN vs ND, and the vast majority (56/60) had elevated terminal complement activation (urine sC5b-9). These results provide insights into the pathophysiology of IgAN and suggest the potential clinical utility of soluble biomarkers in this heterogenous disease.

Note: This abstract was submitted to American Society of Nephrology (ASN) Kidney Week 2025 Annual Meeting (Houston, TX, USA, November 6–9, 2025; Cammett T, et al. PUB222. https://www.asn-online.org/education/kidneyweek/2025/program-abstract.aspx?controlId=4346617)

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