Lupus NephritisPhase 4NCT07611214
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
A Phase 4 study testing LUPKYNIS, belimumab, obinutuzumab or anifrolumab and mycophenolic acid analog (MPAA) in people with Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. at 27 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- LUPKYNIS, belimumab, obinutuzumab or anifrolumab and mycophenolic acid analog (MPAA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 27 sitesUnited States
- Study dates
- 22 Apr 2026to 2 Mar 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- Intravenous immunoglobulin (IVIg)
- Janus kinase (JAK) inhibitors (eg, upadacitinib)
- Pregnant, breastfeeding or intending to become pregnant during the Study
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 27 recruiting
- Recruiting
Western Nephrology & Metabolic Bone Disease, PC
Arvada, Colorado, 80002
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Novel Research LLC
Bellaire, Texas, 77401
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28202
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Dunes Clinical Research
Dakota Dunes, South Dakota, 57049
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Liberty Research Center
Dallas, Texas, 75230
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Texas Arthritis Center
El Paso, Texas, 79902
Aurinia Clinical Trial Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Integrative Rheumatology of South Texas
Harlingen, Texas, 78550
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Northwest Houston Arthritis Center
Houston, Texas, 77090
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
West Tennessee Research Institute
Jackson, Tennessee, 38305
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Swati Shah MD Rheumatology, LLC
Jacksonville, Florida, 32257
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Kansas City Physician Partners
Kansas City, Missouri, 64151
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Vida Clinical Research
Kissimmee, Florida, 34741
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Purushotham & Akther Kotha MD, Inc.
La Mesa, California, 91942
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, 70605
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
University of Nevada Las Vegas
Las Vegas, Nevada, 89102
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Parris and Associates Rheumatology
Lawrenceville, Georgia, 30044
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Valerius Medical Group & Research Center of Greater Long Beach, Inc.
Los Alamitos, California, 90720
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Texas Tech University Health Science Center
Lubbock, Texas, 79430
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Life Clinical Trials
Margate, Florida, 33063
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Buffalo Rheumatology and Medicine, PLLC
Orchard Park, New York, 14217
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
CTR Oakwater
Orlando, Florida, 32806
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Texas Rheumatology Research Institute, LLC
Plano, Texas, 75024
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Arthritis and Rheumatism Associates
Rockville, Maryland, 20850
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Nephrology Leaders and Associates, PLLC
Van Vleck, Texas, 77482
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, 07764
Aurinia Clinical Trial Information, 833-606-5975, clinicaltrials@auriniapharma.com
- Recruiting
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090
Aurinia Clinical Trials Information, 833-606-5975, clinicaltrials@auriniapharma.com
About this study
Official title: 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
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).
Read the detailed description
Patients with LN will be administered LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab. Additionally, patients will receive treatment with a mycophenolic acid analog (MPAA), specifically mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and oral prednisone (or equivalent).
- Conditions
- Lupus Nephritis
- Being tested
- LUPKYNIS, belimumab, obinutuzumab or anifrolumab, mycophenolic acid analog (MPAA), corticosteroid
- Keywords
- voclosporin, calcineurin inhibitor
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUPKYNISDrug
voclosporin
belimumab, obinutuzumab or anifrolumabBiological
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
mycophenolic acid analog (MPAA)Drug
CELLCEPT (mycophenolate mofetil [MMF]) or MYFORTIC (mycophenolic acid [MPA])
corticosteroidDrug
prednisone (or equivalent)
| Study group | Role | What they receive |
|---|---|---|
| LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab | Experimental | Patients will also receive concomitant mycophenolic acid analog and corticosteroids. Receives: Drug: LUPKYNIS; Biological: belimumab, obinutuzumab or anifrolumab; Drug: mycophenolic acid analog (MPAA); Drug: corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 24 weeks
Secondary outcomes (8)
To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events
Measured: From baseline to study completion, up to 28 weeks
To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with partial renal response at 24 weeks
Measured: 24 weeks
To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with deep renal response rate at 24 weeks
Measured: 24 weeks
To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response
Measured: From baseline to complete renal response, up to 24 weeks
To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to partial renal response
Measured: From baseline to partial renal response, up to 24 weeks
To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of anti-double-stranded deoxyribonucleic acid (dsDNA) autoantibodies at 12 weeks and at 24 weeks
Measured: Baseline, 12 weeks, and 24 weeks
To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 3 (C3) at 12 weeks and at 24 weeks
Measured: Baseline, 12 weeks, and 24 weeks
To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 4 (C4) at 12 weeks and at 24 weeks
Measured: Baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start22 Apr 2026
- Primary completion2 Mar 2029 (estimated)
- Study completion2 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611214
- Sponsor's protocol ID
- AUR-VCS-2025-01
- Status last verified
- Jul 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No