Recruiting

LUPKYNIS® & Belimumab, Obinutuzumab, AnifrolumabPRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

Sponsor:

Aurinia Pharmaceuticals Inc.

Code:

NCT07611214

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LUPKYNIS

belimumab, obinutuzumab or anifrolumab

mycophenolic acid analog (MPAA)

corticosteroid

Study Details

Brief 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).

Conditions

Lupus Nephritis

Study ID

NCT07611214

Start date

Apr 22, 2026

Status verified date

Jul, 2026

Completion date

Mar 2, 2029

Anticipated

Primary completion date

Mar 2, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

Patients will also receive concomitant mycophenolic acid analog and corticosteroids.

Interventions

LUPKYNIS

voclosporin

belimumab, obinutuzumab or anifrolumab

BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)

mycophenolic acid analog (MPAA)

CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])

corticosteroid

prednisone (or equivalent)

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 ]

Central Contacts and Locations

Central contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Locations

Purushotham & Akther Kotha MD, Inc.

Recruiting

La Mesa, California, United States, 91942

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Valerius Medical Group & Research Center of Greater Long Beach, Inc.

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Western Nephrology & Metabolic Bone Disease, PC

Recruiting

Arvada, Colorado, United States, 80002

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Swati Shah MD Rheumatology, LLC

Recruiting

Jacksonville, Florida, United States, 32257

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Vida Clinical Research

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Life Clinical Trials

Recruiting

Margate, Florida, United States, 33063

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

CTR Oakwater

Recruiting

Orlando, Florida, United States, 32806

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Parris and Associates Rheumatology

Recruiting

Lawrenceville, Georgia, United States, 30044

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Accurate Clinical Research, Inc.

Recruiting

Lake Charles, Louisiana, United States, 70605

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Arthritis and Rheumatism Associates

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Kansas City Physician Partners

Recruiting

Kansas City, Missouri, United States, 64151

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

University of Nevada Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Sahni Rheumatology & Therapy

Recruiting

West Long Branch, New Jersey, United States, 07764

Contacts

Aurinia Clinical Trial Information

833-606-5975 clinicaltrials@auriniapharma.com

Buffalo Rheumatology and Medicine, PLLC

Recruiting

Orchard Park, New York, United States, 14217

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Arthritis and Osteoporosis Consultants of the Carolinas

Recruiting

Charlotte, North Carolina, United States, 28202

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Joint and Muscle Research Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Rheumatic Disease Associates, Ltd.

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Dunes Clinical Research

Recruiting

Dakota Dunes, South Dakota, United States, 57049

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Novel Research LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Liberty Research Center

Recruiting

Dallas, Texas, United States, 75230

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Texas Arthritis Center

Recruiting

El Paso, Texas, United States, 79902

Contacts

Aurinia Clinical Trial Information

833-606-5975 clinicaltrials@auriniapharma.com

Integrative Rheumatology of South Texas

Recruiting

Harlingen, Texas, United States, 78550

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Northwest Houston Arthritis Center

Recruiting

Houston, Texas, United States, 77090

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Texas Tech University Health Science Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Texas Rheumatology Research Institute, LLC

Recruiting

Plano, Texas, United States, 75024

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Nephrology Leaders and Associates, PLLC

Recruiting

Van Vleck, Texas, United States, 77482

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

More Information

Sponsor

Aurinia Pharmaceuticals Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

voclosporin
calcineurin inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aurinia Pharmaceuticals Inc. on 2026-08-03.