Evidence map›Paper›PMID 40317902›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2025

Effect of Long-Term Voclosporin Treatment on Renal Histology in Patients With Active Lupus Nephritis With Repeat Renal Biopsies.

Brad H Rovin, Clarissa Cassol, Samir V Parikh, Amit Saxena, Neil Solomons, Vanessa Birardi, Ernie Yap, Clint W Abner, David R W Jayne, Robert B Huizinga

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Observational
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Brad H RovinOhio State University Wexner Medical Center, Columbus.ORCID https://orcid.org/0000-0001-5639-0210
Clarissa CassolArkana Laboratories, Little Rock, Arkansas.
Samir V ParikhOhio State University Wexner Medical Center, Columbus.ORCID https://orcid.org/0000-0001-7023-525X
Amit SaxenaNew York University School of Medicine, New York.ORCID https://orcid.org/0000-0003-0098-1083
Neil SolomonsNeil Solomons Consulting, North Saanich, British Columbia, Canada.
Vanessa BirardiAurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada.ORCID https://orcid.org/0000-0002-5429-7546
Ernie YapAurinia Pharmaceuticals Inc, Edmonton, Alberta, Canada.
Clint W AbnerNovartis Pharmaceuticals, East Hanover, New Jersey.
David R W JayneSchool of Clinical Medicine, University of Cambridge, Cambridge, United Kingdom.ORCID https://orcid.org/0000-0002-1712-0637
Robert B HuizingaReformation Consulting Services, North Saanich, British Columbia, Canada.ORCID https://orcid.org/0000-0001-8703-7655

Funding

Aurinia Pharmaceuticals Inc.
6 · The paper itself

Abstract

objectiveThis study characterized the impact of voclosporin on kidney histology in patients with lupus nephritis (LN) who had protocolized repeat kidney biopsies in the AURORA clinical trials.

methodsPatients were randomized to voclosporin or placebo treatment for up to 3 years; all patients received mycophenolate mofetil and low-dose glucocorticoids. Patients had baseline kidney biopsies within 6 months before study start and repeat biopsies after approximately 18 months of study treatment. The revised National Institutes of Health indices for LN activity and chronicity (CI) were calculated in addition to a semiquantitative assessment of vascular and tubular lesions.

resultsSixteen patients in the voclosporin group and 10 patients in the control group had both baseline and repeat kidney biopsies. Patient clinical characteristics were similar at baseline. In the voclosporin group, most (n = 13) patients had pure class IV lesions (pure class V, n = 1; mixed, n = 2). In the control group, three patients had pure class IV (pure class III, n = 3; pure class V, n = 1; mixed, n = 3). Most of the voclosporin-treated patients had no change in CI (n = 8) or a change no greater than 2 (n = 6); control-treated patients also had no change in CI (n = 3) or a change no greater than 2 (n = 6). No trends in vascular lesions or tubular compartment changes were observed.

conclusionOutcomes from this small subgroup show that exposure to study treatment was not associated with nephrotoxicity based on histopathologic evaluation after 18 months. These data are reassuring and further contribute to the safety profile of voclosporin for the treatment of adults with active LN.

Indexed as

CyclosporineImmunosuppressive AgentsKidneyLupus NephritisAdultBiopsyFemaleGlucocorticoidsHumansMaleMiddle AgedMycophenolic AcidTreatment OutcomeYoung AdultCyclosporineGlucocorticoidsImmunosuppressive AgentsMycophenolic Acidvoclosporin

Identifiers

PMID40317902
PMCPMC12479183

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.