PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
Aurinia Pharmaceuticals Inc. · NCT07611214
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 150
- US sites recruiting
- 27
- Study start
- April 22, 2026
- Record last updated
- August 3, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: LUPKYNIS; belimumab, obinutuzumab or anifrolumab; mycophenolic acid analog (MPAA); corticosteroid
Conditions: Lupus Nephritis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Purushotham & Akther Kotha MD, Inc.
La Mesa, CA 91942
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Valerius Medical Group & Research Center of Greater Long Beach, Inc.
Los Alamitos, CA 90720
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Western Nephrology & Metabolic Bone Disease, PC
Arvada, CO 80002
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Swati Shah MD Rheumatology, LLC
Jacksonville, FL 32257
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Vida Clinical Research
Kissimmee, FL 34741
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Life Clinical Trials
Margate, FL 33063
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
CTR Oakwater
Orlando, FL 32806
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Parris and Associates Rheumatology
Lawrenceville, GA 30044
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Accurate Clinical Research, Inc.
Lake Charles, LA 70605
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Arthritis and Rheumatism Associates
Rockville, MD 20850
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Kansas City Physician Partners
Kansas City, MO 64151
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
University of Nevada Las Vegas
Las Vegas, NV 89102
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Sahni Rheumatology & Therapy
West Long Branch, NJ 07764
Site contact: Aurinia Clinical Trial Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Buffalo Rheumatology and Medicine, PLLC
Orchard Park, NY 14217
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, NC 28202
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Joint and Muscle Research Institute
Charlotte, NC 28204
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Rheumatic Disease Associates, Ltd.
Willow Grove, PA 19090
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Dunes Clinical Research
Dakota Dunes, SD 57049
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
West Tennessee Research Institute
Jackson, TN 38305
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Novel Research LLC
Bellaire, TX 77401
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Liberty Research Center
Dallas, TX 75230
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Texas Arthritis Center
El Paso, TX 79902
Site contact: Aurinia Clinical Trial Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Integrative Rheumatology of South Texas
Harlingen, TX 78550
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Northwest Houston Arthritis Center
Houston, TX 77090
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Texas Tech University Health Science Center
Lubbock, TX 79430
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Texas Rheumatology Research Institute, LLC
Plano, TX 75024
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Nephrology Leaders and Associates, PLLC
Van Vleck, TX 77482
Site contact: Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com
Study contacts (from the official record)
- Aurinia Clinical Trials Information · 833-606-5975 · clinicaltrials@auriniapharma.com