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Phase 4Recruiting

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

Sponsored by Aurinia Pharmaceuticals Inc.

About this study

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).

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).

Where this study is enrolling (27)

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

    Los Alamitos, California

    I'm interested

  • Purushotham & Akther Kotha MD, Inc.

    La Mesa, California

    I'm interested

  • Western Nephrology & Metabolic Bone Disease, PC

    Arvada, Colorado

    I'm interested

  • Swati Shah MD Rheumatology, LLC

    Jacksonville, Florida

    I'm interested

  • Life Clinical Trials

    Margate, Florida

    I'm interested
Show all 27 locations
Who can participate

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

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.