TrialPath
Recruiting

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

NCT07611214 · Aurinia Pharmaceuticals Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
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).
Eligibility 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
Study design
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-22
Estimated completion: 2029-03-02
Last updated: 2026-05-28
Interventions
Drug: LUPKYNISBiological: belimumab, obinutuzumab or anifrolumabDrug: mycophenolic acid analog (MPAA)Drug: corticosteroid
Primary outcomes
  • 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 (24 weeks)
Sponsor
Aurinia Pharmaceuticals Inc. · industry
Contacts & investigators
ContactAurinia Clinical Trials Information · contact · clinicaltrials@auriniapharma.com · 833-606-5975
All locations (10)
Valerius Medical Group & Research Center of Greater Long Beach, Inc.Recruiting
Los Alamitos, California, United States
Swati Shah MD Rheumatology, LLCRecruiting
Jacksonville, Florida, United States
CTR OakwaterRecruiting
Orlando, Florida, United States
Accurate Clinical Research, Inc.Recruiting
Lake Charles, Louisiana, United States
Arthritis and Osteoporosis Consultants of the CarolinasRecruiting
Charlotte, North Carolina, United States
Joint and Muscle Research InstituteRecruiting
Charlotte, North Carolina, United States
West Tennessee Research InstituteRecruiting
Jackson, Tennessee, United States
Liberty Research CenterRecruiting
Dallas, Texas, United States
Texas Rheumatology Research Institute, LLCRecruiting
Plano, Texas, United States
Nephrology Leaders and Associates, PLLCRecruiting
Van Vleck, Texas, United States
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis · TrialPath