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Lupus kidney trial aims for faster remission with drug cocktail

NCT ID NCT07611214

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether adding LUPKYNIS to standard biologic therapies (belimumab, obinutuzumab, or anifrolumab) can quickly improve kidney function in people with lupus nephritis. About 150 adults with biopsy-confirmed lupus kidney disease will receive the combination treatment. The main goal is to see how many achieve complete kidney response within 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accurate Clinical Research, Inc.

    RECRUITING

    Lake Charles, Louisiana, 70605, United States

  • Arthritis and Osteoporosis Consultants of the Carolinas

    RECRUITING

    Charlotte, North Carolina, 28202, United States

  • Arthritis and Rheumatism Associates

    RECRUITING

    Rockville, Maryland, 20850, United States

  • Buffalo Rheumatology and Medicine, PLLC

    RECRUITING

    Orchard Park, New York, 14217, United States

  • CTR Oakwater

    RECRUITING

    Orlando, Florida, 32806, United States

  • Dunes Clinical Research

    RECRUITING

    Dakota Dunes, South Dakota, 57049, United States

  • Integrative Rheumatology of South Texas

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Joint and Muscle Research Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Kansas City Physician Partners

    RECRUITING

    Kansas City, Missouri, 64151, United States

  • Liberty Research Center

    RECRUITING

    Dallas, Texas, 75230, United States

  • Life Clinical Trials

    RECRUITING

    Margate, Florida, 33063, United States

  • Nephrology Leaders and Associates, PLLC

    RECRUITING

    Van Vleck, Texas, 77482, United States

  • Northwest Houston Arthritis Center

    RECRUITING

    Houston, Texas, 77090, United States

  • Novel Research LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Parris and Associates Rheumatology

    RECRUITING

    Lawrenceville, Georgia, 30044, United States

  • Purushotham & Akther Kotha MD, Inc.

    RECRUITING

    La Mesa, California, 91942, United States

  • Rheumatic Disease Associates, Ltd.

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Sahni Rheumatology & Therapy

    RECRUITING

    West Long Branch, New Jersey, 07764, United States

  • Swati Shah MD Rheumatology, LLC

    RECRUITING

    Jacksonville, Florida, 32257, United States

  • Texas Arthritis Center

    RECRUITING

    El Paso, Texas, 79902, United States

  • Texas Rheumatology Research Institute, LLC

    RECRUITING

    Plano, Texas, 75024, United States

  • Texas Tech University Health Science Center

    RECRUITING

    Lubbock, Texas, 79430, United States

  • University of Nevada Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89102, United States

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

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Vida Clinical Research

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Western Nephrology & Metabolic Bone Disease, PC

    RECRUITING

    Arvada, Colorado, 80002, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.