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PRESERVE: LUPKYNIS for Lupus Nephritis

This study is looking at how well LUPKYNIS (voclosporin) works when combined with other medications like BENLYSTA (belimumab), GAZYVA (obinutuzumab), or SAPHNELO (anifrolumab) for people with lupus nephritis (kidney inflammation caused by lupus). You would also receive standard treatments like mycophenolic acid (CELLCEPT or MYFORTIC) and prednisone. The main goal is to see how many patients achieve a rapid improvement in their kidney function within 24 weeks. The study is enrolling 150 adults aged 18-75 who have been diagnosed with lupus nephritis and meet specific urine protein levels. The current recruitment status is unclear.

Study design
This study is an interventional study, meaning participants will receive specific treatments. It aims to enroll 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 weeks, focusing on complete renal response at that time.

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NCT07611214

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

Recruiting
PHASE4Ages 18–75InterventionalTreatment
Aurinia Pharmaceuticals Inc.
~150 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:LUPKYNISbelimumab, obinutuzumab or anifrolumabmycophenolic acid analog (MPAA)corticosteroid

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with complete renal response at 24 weeks
Measured over 24 weeks

Conditions

Lupus Nephritis

Explore related trials

Lupus Glomerulonephritis

Where it's being run

27 sites across 15 states
Texas8
Florida4
California2
North Carolina2
Colorado1
Georgia1
Louisiana1
Maryland1

Who to contact

Aurinia Clinical Trials Information
[email protected]
833-606-5975
Email the study team

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Eligibility criteria

Inclusion

Adults 18-75 years old
Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V)
Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and \<5.0 g/g from a first morning void (FMV) urine sample
Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2
Concomitant biologic:
Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1.
Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening.
Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1
Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \[or equivalent\]) or by initiating on or before Day 1

Exclusion

Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range
Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening
Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \[or equivalent\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening:
Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)
Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)
T cell costimulation modulator (eg, abatacept)
Intravenous immunoglobulin (IVIg)
Janus kinase (JAK) inhibitors (eg, upadacitinib)
Pregnant, breastfeeding or intending to become pregnant during the Study

What this trial measures

  • To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with complete renal response at 24 weeks24 weeks