LUPKYNIS Combined With Another Biologic Drug for Lupus Nephritis
Tests LUPKYNIS plus a second drug in adults with lupus nephritis.
Plain-language title generated from the registry record
Registry title: PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
Key facts
- Where
- Arvada, Bellaire, Charlotte, Dakota Dunes, Dallas, El Paso, Harlingen, Houston, Jackson, Jacksonville, Kansas City, Kissimmee, La Mesa, Lake Charles, Las Vegas, Lawrenceville, Los Alamitos, Lubbock, Margate, Orchard Park, Orlando, Plano, Rockville, Van Vleck, West Long Branch, and Willow Grove, United StatesSee the 27 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07611214, who can take part
Where in United States
- Western Nephrology & Metabolic Bone Disease, PCArvada, United StatesTaking people
- Novel Research LLCBellaire, United StatesTaking people
- Arthritis and Osteoporosis Consultants of the CarolinasCharlotte, United StatesTaking people
- Joint and Muscle Research InstituteCharlotte, United StatesTaking people
- Dunes Clinical ResearchDakota Dunes, United StatesTaking people
- Liberty Research CenterDallas, United StatesTaking people
- Texas Arthritis CenterEl Paso, United StatesTaking people
- Integrative Rheumatology of South TexasHarlingen, United StatesTaking people
- Northwest Houston Arthritis CenterHouston, United StatesTaking people
- West Tennessee Research InstituteJackson, United StatesTaking people
- Swati Shah MD Rheumatology, LLCJacksonville, United StatesTaking people
- Kansas City Physician PartnersKansas City, United StatesTaking people
- Vida Clinical ResearchKissimmee, United StatesTaking people
- Purushotham & Akther Kotha MD, IncLa Mesa, United StatesTaking people
- Accurate Clinical Research, IncLake Charles, United StatesTaking people
- University of Nevada Las VegasLas Vegas, United StatesTaking people
- Parris and Associates RheumatologyLawrenceville, United StatesTaking people
- Valerius Medical Group & Research Center of Greater Long Beach, Inc.Los Alamitos, United StatesTaking people
- Texas Tech University Health Science CenterLubbock, United StatesTaking people
- Life Clinical TrialsMargate, United StatesTaking people
- Buffalo Rheumatology and Medicine, PLLCOrchard Park, United StatesTaking people
- CTR OakwaterOrlando, United StatesTaking people
- Texas Rheumatology Research Institute LLCPlano, United StatesTaking people
- Arthritis and Rheumatism AssociatesRockville, United StatesTaking people
- Nephrology Leaders and Associates, PLLCVan Vleck, United StatesTaking people
- Sahni Rheumatology & TherapyWest Long Branch, United StatesTaking people
- Rheumatic Disease Associates, Ltd.Willow Grove, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aurinia Pharmaceuticals Inc.
- Trial code
- NCT07611214
- Record updated
- 3 August 2026
- Original description
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 full original descriptionShow less
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).
Inclusion: 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.
Exclusion: 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); 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; Pregnant, breastfeeding or intending to become pregnant during the Study.