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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

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
Are there results?: Not yet: the study is under way

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.

Show all 9Show fewer

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)

Show all 9Show fewer

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.

Aurinia Clinical Trials Information contact

833-606-5975

clinicaltrials@auriniapharma.com

City, postcode or hospital

Sites recruiting now only

27 sites in 1 country

United States27 sites, 27 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
Recruiting

Other trials in United States

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

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 groups in NCT07611214
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.

22 Apr 20262 Mar 2029

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)

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

Interested in taking part?

Aurinia Clinical Trials Information

833-606-5975

clinicaltrials@auriniapharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

All Lupus Nephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07611214
Acronym / sponsor ID: AUR-VCS-2025-01
Conditions: Lupus Nephritis
Keywords: voclosporin, calcineurin inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 22 Apr 2026 (actual)
Primary completion: 2 Mar 2029 (estimated)
Study completion: 2 Mar 2029 (estimated)
First posted: 28 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab	Experimental	Drug: LUPKYNIS, Biological: belimumab, obinutuzumab or anifrolumab, Drug: mycophenolic acid analog (MPAA), Drug: corticosteroidPatients will also receive concomitant mycophenolic acid analog and corticosteroids.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (9 listed)

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:
Pregnant, breastfeeding or intending to become pregnant during the Study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LUPKYNISvoclosporin	Drug	LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
belimumab, obinutuzumab or anifrolumabBENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)	Biological	LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
mycophenolic acid analog (MPAA)CELLCEPT (mycophenolate mofetil [MMF]) or MYFORTIC (mycophenolic acid [MPA])	Drug	LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
corticosteroidprednisone (or equivalent)	Drug	LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

Primary outcome

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
Time frame: 24 weeks

8 secondary outcomes

To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events
Time frame: 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
Time frame: 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
Time frame: 24 weeks
To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 weeks, and 24 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.

Related trials for Lupus Nephritis

RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Aurinia Clinical Trials Information contact

833-606-5975

clinicaltrials@auriniapharma.com

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurinia Clinical Trials Information (833-606-5975, clinicaltrials@auriniapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07611214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.