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

2026年7月31日 更新者：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).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (估计的)

150

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
Patients will also receive concomitant mycophenolic acid analog and corticosteroids.
药品：LUPKYNIS
voclosporin
生物：belimumab, obinutuzumab or anifrolumab
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
药品：mycophenolic acid analog (MPAA)
CELLCEPT (mycophenolate mofetil [MMF]) or MYFORTIC (mycophenolic acid [MPA])
药品：corticosteroid
prednisone (or equivalent)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
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
大体时间：24 weeks
24 weeks

次要结果测量

结果测量
大体时间
To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline, 12 weeks, and 24 weeks
Baseline, 12 weeks, and 24 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Aurinia Pharmaceuticals Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月22日

初级完成 (估计的)

2029年3月2日

研究完成 (估计的)

2029年3月2日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AUR-VCS-2025-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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