Can a single drug calm lupus kidney disease without a cocktail of meds?

NCT ID NCT07721363

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase II trial tests whether obinutuzumab, a B-cell targeting antibody, can alone achieve complete kidney response in people with pure class V lupus nephritis—a form of lupus kidney disease with no approved treatments. Participants receive up to four infusions over seven months and are followed for a year. The study aims to see if this approach can reduce protein in the urine and preserve kidney function without the need for other immunosuppressants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obinutuzumab (also known as GAZYVARO), a B-cell targeting antibody given as intravenous infusions
What this could lead to
If successful, this could provide a targeted treatment option for a form of lupus kidney disease that currently has no approved therapy.
What could go wrong
This is an early-phase trial with only 65 participants, so results may not apply broadly. Obinutuzumab can cause infusion reactions and increase infection risk.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 65 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion Criteria: 1. Diagnosis of SLE fulfilling the 2019 EULAR/ACR classification criteria (score \> 10) 2. Age from 18 to 75 years old included 3. Pure class V lupus nephritis, defined on a renal biopsy sample following the ISN/RPS 2003 criteria AND * Nephrotic range proteinuria (UPCr or UACr \> 3 g/g) at screening visit OR * Uncontrolled proteinuria after at least 3 months of well-conducted anti-proteinuric therapy \[UPCR\> 1 g/g despite maximal or maximally tolerated dose of ACEi or ARB + SGLT2i therapy +/- diuretic therapy\] and up to 12 months after pure class V lupus nephritis diagnosis. 4. For women of childbearing age, agreement to remain abstinent (refrain from heterosexual intercourse) or willingness to use appropriate and effective contraception, as recommended when using obinutuzumab (18 months after last infusion) 5. Signature of informed consent 6. French social security affiliation (beneficiary or legal) 7. Time interval between kidney biopsy showing pure class V LN and baseline visit of no more than 12 months Exclusion Criteria: 1. Ongoing treatment (induction or maintenance) for proliferative LN (class III-A or IV-A) 2. Negativity for anti-nuclear antibodies (\< 1/80) on immunofluorescence assay 3. Severe extra-renal (i.e but not limited to : cardiac, central nervous system, pulmonary, enteric) lupus flare requiring high dose (\> 1 mg/kg/day) corticosteroids. 4. Receipt of any of the following excluded therapies: * Any anti-CD20 therapy such as rituximab, ocrelizumab, or ofatumumab less than 6 months prior to screening or during screening. If an anti-CD20 therapy has been received between 6 and 12 months prior to screening, the peripheral CD19+ B-cell count by flow cytometry must be \> 25 cells/µL * Cyclophosphamide, tacrolimus, ciclosporin, mycophenolate mofetil, pulse methylprednisolone or voclosporin during the 2 months prior to screening or during screening. Patients maintained on low-dose corticosteroids (\<10 mg/day prednisone equivalent) for a prolonged period as part of the management of a previous and resolved flare are eligible for trial participation. * Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening * Oral inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening * Any live vaccine during the 28 days prior to screening or during screening 5. Contraindication to the use of obinutuzumab, its premedication drugs or hypersensitivity to its excipients. 6. Fewer than 10 non-sclerosed glomeruli analyzable on renal biopsy 7. Ongoing pregnancy or breastfeeding women 8. CKD stage 4 or 5, defined as eGFR \<30 ml/min/1.73m2 according to CKD-EPI creatinine equation measured two times in an interval of 3 months (to be dissociated from acute kidney injury). 9. Obsolescence of more than 60% of glomeruli or tubulo-interstitial scarring of more than 60% on kidney biopsy. 10. Patients already included in an interventional study (RIPH1, clinical investigation or clinical trial) 11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom 12. Patients with a previously documented kidney disease causing proteinuria (\> 3 g/g or \> 3 g/day) more than 1 year prior to the diagnosis of pure class V LN. 13. Exclusion of primary membranous nephropathy, defined by positive anti-PLA2R antibodies on serum and/or glomerular PLA2R staining on kidney biopsy

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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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Sorbonne University - Nephrology Départment - Tenon APHP

    Paris, France, 75012, France

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