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Clinical Trials in the USA / NCT07611214
Recruiting Phase 4

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

NCT07611214 · tracked via the Priya Life Science USA tracker
Sponsor
Aurinia Pharmaceuticals Inc.
Phase
Phase 4
Started
2026-04-22
Last updated
2026-08-03

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

LUPKYNISbelimumab, obinutuzumab or anifrolumabmycophenolic acid analog (MPAA)corticosteroid

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)

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Purushotham & Akther Kotha MD, Inc. La Mesa California Recruiting
Valerius Medical Group & Research Center of Greater Long Beach, Inc. Los Alamitos California Recruiting
Western Nephrology & Metabolic Bone Disease, PC Arvada Colorado Recruiting
Swati Shah MD Rheumatology, LLC Jacksonville Florida Recruiting
Vida Clinical Research Kissimmee Florida Recruiting
Life Clinical Trials Margate Florida Recruiting
CTR Oakwater Orlando Florida Recruiting
Parris and Associates Rheumatology Lawrenceville Georgia Recruiting
Accurate Clinical Research, Inc. Lake Charles Louisiana Recruiting
Arthritis and Rheumatism Associates Rockville Maryland Recruiting
Kansas City Physician Partners Kansas City Missouri Recruiting
University of Nevada Las Vegas Las Vegas Nevada Recruiting
Sahni Rheumatology & Therapy West Long Branch New Jersey Recruiting
Buffalo Rheumatology and Medicine, PLLC Orchard Park New York Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina Recruiting
Joint and Muscle Research Institute Charlotte North Carolina Recruiting
Rheumatic Disease Associates, Ltd. Willow Grove Pennsylvania Recruiting
Dunes Clinical Research Dakota Dunes South Dakota Recruiting
West Tennessee Research Institute Jackson Tennessee Recruiting
Novel Research LLC Bellaire Texas Recruiting
Liberty Research Center Dallas Texas Recruiting
Texas Arthritis Center El Paso Texas Recruiting
Integrative Rheumatology of South Texas Harlingen Texas Recruiting
Northwest Houston Arthritis Center Houston Texas Recruiting
Texas Tech University Health Science Center Lubbock Texas Recruiting
Texas Rheumatology Research Institute, LLC Plano Texas Recruiting
Nephrology Leaders and Associates, PLLC Van Vleck Texas Recruiting

More Aurinia Pharmaceuticals Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07611214 on ClinicalTrials.gov ↗ ← All trials in the USA