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

RecruitingPhase 4

PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

About the study

The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).

What is being tested

Sponsor: Aurinia Pharmaceuticals Inc. · Participants: 150 · Started: Apr 22, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07611214

Locations in the U.S.

CaliforniaPurushotham & Akther Kotha MD, Inc., La Mesa
Valerius Medical Group & Research Center of Greater Long Beach, Inc., Los Alamitos
ColoradoWestern Nephrology & Metabolic Bone Disease, PC, Arvada
FloridaSwati Shah MD Rheumatology, LLC, Jacksonville
Vida Clinical Research, Kissimmee
Life Clinical Trials, Margate
CTR Oakwater, Orlando
GeorgiaParris and Associates Rheumatology, Lawrenceville
LouisianaAccurate Clinical Research, Inc., Lake Charles
MarylandArthritis and Rheumatism Associates, Rockville
MissouriKansas City Physician Partners, Kansas City
NevadaUniversity of Nevada Las Vegas, Las Vegas
New JerseySahni Rheumatology & Therapy, West Long Branch
New YorkBuffalo Rheumatology and Medicine, PLLC, Orchard Park
North CarolinaArthritis and Osteoporosis Consultants of the Carolinas, Charlotte
Joint and Muscle Research Institute, Charlotte
PennsylvaniaRheumatic Disease Associates, Ltd., Willow Grove
South DakotaDunes Clinical Research, Dakota Dunes
TennesseeWest Tennessee Research Institute, Jackson
TexasNovel Research LLC, Bellaire
Liberty Research Center, Dallas
Texas Arthritis Center, El Paso
Integrative Rheumatology of South Texas, Harlingen
Northwest Houston Arthritis Center, Houston
Texas Tech University Health Science Center, Lubbock
Texas Rheumatology Research Institute, LLC, Plano
Nephrology Leaders and Associates, PLLC, Van Vleck

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.