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

NCT07611214 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: AUR-VCS-2025-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 15

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

Keywords

voclosporin; calcineurin inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events

  From baseline to study completion, up to 28 weeks

• To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with partial renal response at 24 weeks

  24 weeks

• To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with deep renal response rate at 24 weeks

  24 weeks

• To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response

  From baseline to complete renal response, up to 24 weeks

• To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to partial renal response

  From baseline to partial renal response, up to 24 weeks

Study Arms (1)

LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

EXPERIMENTAL

Patients will also receive concomitant mycophenolic acid analog and corticosteroids.

Drug: LUPKYNIS; Biological: belimumab, obinutuzumab or anifrolumab; Drug: mycophenolic acid analog (MPAA); Drug: corticosteroid

Interventions

LUPKYNIS DRUG

voclosporin

LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

belimumab, obinutuzumab or anifrolumab BIOLOGICAL

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

LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

mycophenolic acid analog (MPAA) DRUG

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

LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

corticosteroid DRUG

prednisone (or equivalent)

LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (15)

Purushotham & Akther Kotha MD, Inc.

La Mesa, California, 91942, United States

RECRUITING

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

Los Alamitos, California, 90720, United States

RECRUITING

Swati Shah MD Rheumatology, LLC

Jacksonville, Florida, 32257, United States

RECRUITING

CTR Oakwater

Orlando, Florida, 32806, United States

RECRUITING

Parris and Associates Rheumatology

Lawrenceville, Georgia, 30044, United States

RECRUITING

Accurate Clinical Research, Inc.

Lake Charles, Louisiana, 70605, United States

RECRUITING

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, 28202, United States

RECRUITING

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

RECRUITING

Novel Research LLC

Bellaire, Texas, 77401, United States

RECRUITING

Liberty Research Center

Dallas, Texas, 75230, United States

RECRUITING

Integrative Rheumatology of South Texas

Harlingen, Texas, 78550, United States

RECRUITING

Northwest Houston Arthritis Center

Houston, Texas, 77090, United States

RECRUITING

Texas Rheumatology Research Institute, LLC

Plano, Texas, 75024, United States

RECRUITING

Nephrology Leaders and Associates, PLLC

Van Vleck, Texas, 77482, United States

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin; belimumab; obinutuzumab; anifrolumab; Mycophenolic Acid; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Aurinia Clinical Trials Information

CONTACT

833-606-5975; clinicaltrials@auriniapharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 28, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): March 2, 2029
• Study Completion (Estimated): March 2, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (15)