CHANGE IN SOLUBLE BIOMARKER LEVELS IN PATIENTS WITH IgA NEPHROPATHY: AN ANALYSIS OF THE PHASE 2 TRIAL OF RAVULIZUMAB (SANCTUARY)

 

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https://storage.unitedwebnetwork.com/files/1099/81b46b20f2a79da45f7e8a6b1b90a009.pdf
CHANGE IN SOLUBLE BIOMARKER LEVELS IN PATIENTS WITH IgA NEPHROPATHY: AN ANALYSIS OF THE PHASE 2 TRIAL OF RAVULIZUMAB (SANCTUARY)

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Jonathan
Barratt
Tobin J. Cammett tobin.cammett@alexion.com Alexion, AstraZeneca Rare Disease Translational Biomarker Research New Haven, CT United States -
Ellen E. Millman ellen.millman@alexion.com Alexion, AstraZeneca Rare Disease Translational Biomarker Research New Haven, CT United States -
Julio C. Luna Julio.Luna@alexion.com Alexion, AstraZeneca Rare Disease Translational Biomarker Research New Haven, CT United States -
Kara Rice kara.rice@alexion.com Alexion, AstraZeneca Rare Disease Biostatistics Boston, MA United States -
Katherine Garlo Katherine.garlo@alexion.com Alexion, AstraZeneca Rare Disease Clinical Development Boston, MA United States -
Andreas Kateifides andreas.kateifides@alexion.com Alexion, AstraZeneca Rare Disease Clinical Development Boston, MA United States -
Stephen Nolan stephen.nolan@alexion.com Alexion, AstraZeneca Rare Disease Clinical Development Dublin Ireland -
Cory Williams cory.williams@alexion.com Alexion, AstraZeneca Rare Disease Clinical Development New Haven, CT United States -
Richard A. Lafayette czar@stanford.edu Stanford University Medical Center Stanford Glomerular Disease Center Stanford, CA United States -
Jonathan Barratt jb81@leicester.ac.uk University of Leicester Department of Cardiovascular Sciences Leicester United Kingdom * -
Youssef M.K. Farag Youssef.farag@alexion.com Alexion, AstraZeneca Rare Disease Clinical Development Boston, MA United States -
 
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Complement activation plays an important role in the pathophysiology of IgA nephropathy (IgAN), leading to inflammation and progressive kidney damage. In a Phase 2 trial, clinically meaningful proteinuria reduction was observed with the complement C5 inhibitor, ravulizumab (RAV) [1]. Here, we evaluated change over time in soluble biomarkers in patients (pts) treated with RAV vs placebo (PBO). 

In SANCTUARY (NCT04564339), 66 adults with IgAN were randomized (2:1) to RAV (IV q8w) or placebo (PBO) for 26 weeks. Spot urine was collected pre-dose on Days 1, 15, 71, 127, and 183. Evaluable data were available from 60 pts. Validated immunoassays were performed on spot urine and soluble biomarker levels were normalized to urine creatinine (Cr). Longitudinal changes in biomarker levels were reported using descriptive statistics and a mixed model for repeated measures (MMRM) to compare RAV with PBO. 

With RAV, there was early (by Day 15), sustained, and marked reduction in sC5b-9/Cr and Ba/Cr (complement pathway products) (Figures 1-2). Sustained reduction in CD163/Cr (macrophage renal infiltration marker) was observed starting at Day 71. MMRM analysis of change from baseline to Week 26 showed significant reduction in sC5b-9/Cr, Ba/Cr, CD163/Cr, and KIM-1/Cr (proximal tubule injury marker) with RAV vs PBO (Figures 1-4).




Figure 1. Change in urine sC5b-9 levels with ravulizumab vs placebo

Figure 2. Change in urine Ba levels with ravulizumab vs placebo

Figure 3. Change in urine CD163 levels with ravulizumab vs placebo

In pts treated with RAV, there was an early and sustained reduction in biomarkers of complement activation and reduction in markers of macrophage renal infiltration and tubular injury. These results suggest reduced inflammation and kidney damage in response to C5 (terminal complement) inhibition and are consistent with the observed proteinuria reduction in SANCTUARY [1].

Note: This abstract was submitted and has been accepted for oral presentation at the American Society of Nephrology (ASN) Kidney Week 2025 Annual Meeting (Houston, TX, USA; November 6–9, 2025) [2].

[1]. Lafayette R, et al. J Am Soc Nephrol. 2025;36(4):645–656.

[2]. Cammett T, et al. TH-OR043. https://www.asn-online.org/education/kidneyweek/2025/program-abstract.aspx?controlId=4346656


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