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

July 31, 2026 updated by: 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
Patients will also receive concomitant mycophenolic acid analog and corticosteroids.
Drug: LUPKYNIS
voclosporin
Biological: belimumab, obinutuzumab or anifrolumab
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
Drug: mycophenolic acid analog (MPAA)
CELLCEPT (mycophenolate mofetil [MMF]) or MYFORTIC (mycophenolic acid [MPA])
Drug: corticosteroid
prednisone (or equivalent)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 12 weeks, and 24 weeks
Baseline, 12 weeks, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aurinia Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AUR-VCS-2025-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings