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Lupus kidney trial aims for faster remission with drug cocktail
NCT ID NCT07611214
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
27 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Accurate Clinical Research, Inc.
RECRUITINGLake Charles, Louisiana, 70605, United States
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Arthritis and Osteoporosis Consultants of the Carolinas
RECRUITINGCharlotte, North Carolina, 28202, United States
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Arthritis and Rheumatism Associates
RECRUITINGRockville, Maryland, 20850, United States
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Buffalo Rheumatology and Medicine, PLLC
RECRUITINGOrchard Park, New York, 14217, United States
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CTR Oakwater
RECRUITINGOrlando, Florida, 32806, United States
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Dunes Clinical Research
RECRUITINGDakota Dunes, South Dakota, 57049, United States
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Integrative Rheumatology of South Texas
RECRUITINGHarlingen, Texas, 78550, United States
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Joint and Muscle Research Institute
RECRUITINGCharlotte, North Carolina, 28204, United States
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Kansas City Physician Partners
RECRUITINGKansas City, Missouri, 64151, United States
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Liberty Research Center
RECRUITINGDallas, Texas, 75230, United States
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Life Clinical Trials
RECRUITINGMargate, Florida, 33063, United States
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Nephrology Leaders and Associates, PLLC
RECRUITINGVan Vleck, Texas, 77482, United States
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Northwest Houston Arthritis Center
RECRUITINGHouston, Texas, 77090, United States
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Novel Research LLC
RECRUITINGBellaire, Texas, 77401, United States
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Parris and Associates Rheumatology
RECRUITINGLawrenceville, Georgia, 30044, United States
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Purushotham & Akther Kotha MD, Inc.
RECRUITINGLa Mesa, California, 91942, United States
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Rheumatic Disease Associates, Ltd.
RECRUITINGWillow Grove, Pennsylvania, 19090, United States
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Sahni Rheumatology & Therapy
RECRUITINGWest Long Branch, New Jersey, 07764, United States
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Swati Shah MD Rheumatology, LLC
RECRUITINGJacksonville, Florida, 32257, United States
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Texas Arthritis Center
RECRUITINGEl Paso, Texas, 79902, United States
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Texas Rheumatology Research Institute, LLC
RECRUITINGPlano, Texas, 75024, United States
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Texas Tech University Health Science Center
RECRUITINGLubbock, Texas, 79430, United States
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University of Nevada Las Vegas
RECRUITINGLas Vegas, Nevada, 89102, United States
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Valerius Medical Group & Research Center of Greater Long Beach, Inc.
RECRUITINGLos Alamitos, California, 90720, United States
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Vida Clinical Research
RECRUITINGKissimmee, Florida, 34741, United States
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West Tennessee Research Institute
RECRUITINGJackson, Tennessee, 38305, United States
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Western Nephrology & Metabolic Bone Disease, PC
RECRUITINGArvada, Colorado, 80002, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 5,000-Patient registry aims to map the Long-Term course of lupus nephritis
- Can a blood test catch lupus flares earlier?
- Can a single CAR-T infusion reset the immune system and stop lupus kidney damage?
- Blood markers may foretell kidney trouble in lupus
- Can bone marrow stem cells calm lupus kidney flares?
- Can a targeted antibody boost kidney remission in lupus?