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. 2025 Mar 17:5:1540471.
doi: 10.3389/fneph.2025.1540471. eCollection 2025.

The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin

Biff F Palmer  1 , James A Tumlin  2 , Jai Radhakrishnan  3 , Linda M Rehaume  4 , Jennifer L Cross  4 , Robert B Huizinga  4
Affiliations

The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin

Biff F Palmer et al. Front Nephrol. .

Abstract

Objectives: Kidney injury in patients with lupus nephritis (LN) results in pro-fibrotic biomarker expression, a manifestation also observed with calcineurin inhibitor (CNI) therapy. The second-generation CNI, voclosporin, is approved in the United States and Europe for the treatment of patients with active LN in combination with background immunosuppression, based on successful outcomes from the global phase 2 AURA-LV and phase 3 AURORA 1 studies, which demonstrated the efficacy of voclosporin across diverse racial and ethnic populations, and encompassing multiple biopsy classes of LN, alongside a favorable safety profile. This post hoc analysis examined changes from baseline levels of serum and urinary biomarkers, including pro-fibrotic biomarkers, in a cohort of patients from the parent AURORA 1 study.

Methods: Samples were analyzed from a cohort of patients in AURORA 1 treated with voclosporin (23.7 mg twice daily, n=57) or placebo (n=59) in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, including in a subgroup of patients that experienced a ≥30% decline from baseline in estimated glomerular filtration rate (voclosporin, n=26; placebo, n=20).

Results: The addition of voclosporin to MMF and low-dose glucocorticoids for the treatment of LN did not result in significant differences in normalized urinary concentrations of KIM-1, TGF-β1, MCP-1, or NGAL, biomarkers indicative of renal fibrosis and kidney damage, when compared to MMF and low-dose glucocorticoids alone.

Conclusion: These findings further support the safety of voclosporin for the treatment of LN in adult patients.

Clinical trial registration: ClinicalTrials.gov , identifier NCT03021499; EudraCT, identifier 2016-004045-81.

Keywords: biomarker; calcineurin inhibitor; lupus nephritis; nephrotoxicity; voclosporin.

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Conflict of interest statement

JAT reports research grants from Aurinia Pharmaceuticals Inc., JR was on the advisory board and a consultant for Aurinia Pharmaceuticals Inc. LMR is an employee and shareholder of Aurinia Pharmaceuticals Inc., JLC and RBH are former employees of Aurinia Pharmaceuticals Inc. RBH is a consultant and shareholder of Aurinia Pharmaceuticals Inc. The remaining author (BFP) declares that the research was conducted in the absence of any commercial or financial relationships that could be constructed as a potential conflict of interest. The authors declare that this study received funding from Aurinia Pharmaceuticals Inc. The funder had the following involvement in the study: designed, ran, and funded the AURORA 1 clinical trial; provided samples and funded this substudy; and employed LMR, JLC and RBH.

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