Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

31. juli 2026 oppdatert av: Aurinia Pharmaceuticals Inc.

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

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • La Mesa, California, Forente stater, 91942
        • Rekruttering
        • Purushotham & Akther Kotha MD, inc.
        • Ta kontakt med:
      • Los Alamitos, California, Forente stater, 90720
        • Rekruttering
        • Valerius Medical Group & Research Center of Greater Long Beach, Inc.
        • Ta kontakt med:
    • Colorado
      • Arvada, Colorado, Forente stater, 80002
        • Rekruttering
        • Western Nephrology & Metabolic Bone Disease, PC
        • Ta kontakt med:
    • Florida
      • Jacksonville, Florida, Forente stater, 32257
        • Rekruttering
        • Swati Shah MD Rheumatology, LLC
        • Ta kontakt med:
      • Kissimmee, Florida, Forente stater, 34741
      • Margate, Florida, Forente stater, 33063
      • Orlando, Florida, Forente stater, 32806
    • Georgia
      • Lawrenceville, Georgia, Forente stater, 30044
        • Rekruttering
        • Parris and Associates Rheumatology
        • Ta kontakt med:
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70605
        • Rekruttering
        • Accurate Clinical Research, Inc.
        • Ta kontakt med:
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • Rekruttering
        • Arthritis and Rheumatism Associates
        • Ta kontakt med:
    • Missouri
      • Kansas City, Missouri, Forente stater, 64151
        • Rekruttering
        • Kansas City Physician Partners
        • Ta kontakt med:
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89102
        • Rekruttering
        • University of Nevada Las Vegas
        • Ta kontakt med:
    • New Jersey
      • West Long Branch, New Jersey, Forente stater, 07764
        • Rekruttering
        • Sahni Rheumatology & Therapy
        • Ta kontakt med:
    • New York
      • Orchard Park, New York, Forente stater, 14217
        • Rekruttering
        • Buffalo Rheumatology and Medicine, PLLC
        • Ta kontakt med:
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28204
        • Rekruttering
        • Joint and Muscle Research Institute
        • Ta kontakt med:
      • Charlotte, North Carolina, Forente stater, 28202
        • Rekruttering
        • Arthritis and Osteoporosis Consultants of the Carolinas
        • Ta kontakt med:
    • Pennsylvania
      • Willow Grove, Pennsylvania, Forente stater, 19090
        • Rekruttering
        • Rheumatic Disease Associates, Ltd.
        • Ta kontakt med:
    • South Dakota
      • Dakota Dunes, South Dakota, Forente stater, 57049
    • Tennessee
      • Jackson, Tennessee, Forente stater, 38305
        • Rekruttering
        • West Tennessee Research Institute
        • Ta kontakt med:
    • Texas
      • Bellaire, Texas, Forente stater, 77401
      • Dallas, Texas, Forente stater, 75230
      • El Paso, Texas, Forente stater, 79902
      • Harlingen, Texas, Forente stater, 78550
        • Rekruttering
        • Integrative Rheumatology of South Texas
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77090
        • Rekruttering
        • Northwest Houston Arthritis Center
        • Ta kontakt med:
      • Lubbock, Texas, Forente stater, 79430
        • Rekruttering
        • Texas Tech University Health Science Center
        • Ta kontakt med:
      • Plano, Texas, Forente stater, 75024
        • Rekruttering
        • Texas Rheumatology Research Institute, LLC
        • Ta kontakt med:
      • Van Vleck, Texas, Forente stater, 77482
        • Rekruttering
        • Nephrology Leaders and Associates, PLLC
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
Patients will also receive concomitant mycophenolic acid analog and corticosteroids.
Legemiddel: LUPKYNIS
voclosporin
Biologisk: belimumab, obinutuzumab or anifrolumab
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
Legemiddel: mycophenolic acid analog (MPAA)
CELLCEPT (mycophenolate mofetil [MMF]) or MYFORTIC (mycophenolic acid [MPA])
Legemiddel: corticosteroid
prednisone (or equivalent)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 24 weeks
24 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events
Tidsramme: From baseline to study completion, up to 28 weeks
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline to complete renal response, up to 24 weeks
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
Tidsramme: From baseline to partial renal response, up to 24 weeks
From baseline to partial renal response, up to 24 weeks
To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of anti-double-stranded deoxyribonucleic acid (dsDNA) autoantibodies at 12 weeks and at 24 weeks
Tidsramme: Baseline, 12 weeks, and 24 weeks
Baseline, 12 weeks, and 24 weeks
To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 3 (C3) at 12 weeks and at 24 weeks
Tidsramme: Baseline, 12 weeks, and 24 weeks
Baseline, 12 weeks, and 24 weeks
To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 4 (C4) at 12 weeks and at 24 weeks
Tidsramme: Baseline, 12 weeks, and 24 weeks
Baseline, 12 weeks, and 24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aurinia Pharmaceuticals Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. april 2026

Primær fullføring (Antatt)

2. mars 2029

Studiet fullført (Antatt)

2. mars 2029

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AUR-VCS-2025-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere