RightFit
RecruitingPhase 4

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LUPKYNIS taken with belimumab, obinutuzumab, or anifrolumab for lupus nephritis, kidney inflammation caused by lupus. It looks at how safe these treatments are and how quickly they help the kidneys. It is for adults ages 18–75.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–75 years old.
  • A kidney biopsy (tissue sample) shows lupus nephritis class III, IV, III/V, or IV/V.
  • Your first morning urine test shows a protein-to-creatinine ratio of at least 0.5 but less than 5.0 g/g.
  • Your eGFR, a measure of how well your kidneys filter blood, is at least 45 mL/min/1.73 m².
  • If taking belimumab or anifrolumab for this study, you already take it or will start by Day 1.
  • If taking obinutuzumab for this study, you have had at least 2 doses before screening.
  • You are willing to keep taking or start an MPAA medicine, which lowers immune system activity, by Day 1.
  • You are willing to keep taking or start a steroid medicine, such as prednisone, by Day 1.

Who can't join

  • You used a medicine targeting B cells (a type of immune cell) in the year before screening, other than belimumab or obinutuzumab, unless tests show your B cell count is normal.
  • You used cyclophosphamide or a calcineurin inhibitor other than voclosporin in the 3 months before screening. Calcineurin inhibitors lower immune activity; examples include cyclosporine and tacrolimus.
  • You recently used certain other medicines that lower immune activity. The time limit is 30 days before screening or 5 drug half-lives, whichever is longer. A half-life is the time it takes the body to clear half a drug. Exceptions include the allowed study medicines and medicines used to treat your underlying lupus.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (27)

CA

CO

FL

GA

LA

MD

MO

NC

NJ

NV

NY

PA

SD

TN

TX