94% of researchers rate our articles as excellent or good
Learn more about the work of our research integrity team to safeguard the quality of each article we publish.
Find out more
CLINICAL TRIAL article
Front. Nephrol.
Sec. Clinical Research in Nephrology
Volume 5 - 2025 | doi: 10.3389/fneph.2025.1540471
This article is part of the Research Topic Advancement in Kidney Care: Targeted Delivery and Precision Medicine Approaches View all articles
The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin
Provisionally accepted
Biff Palmer 1*
james tumlin 2 Jai Radhakrishnan 3 linda rehaume 4 jennifer cross 4 robert huizinga 4- 1 University of Texas Southwestern Medical Center, Dallas, United States
- 2 nephronet clinical research consortium, atlanta, United States
- 3 Columbia University, New York City, New York, United States
- 4 Aurinia Pharmaceuticals, Victoria, British Columbia, Canada
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 secondgeneration 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).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.These findings further support the safety of voclosporin for the treatment of LN in adult patients.
Keywords: Lupus nephritis1, voclosporin2, biomarker3, nephrotoxicity4, calcineurin inhibitor5
Received: 05 Dec 2024; Accepted: 10 Feb 2025.
Copyright: © 2025 Palmer, tumlin, Radhakrishnan, rehaume, cross and huizinga. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Biff Palmer, University of Texas Southwestern Medical Center, Dallas, United States
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.