Obinutuzumab in patients with pure class V lupus nephritis (systemic lupus erythematosus membranous nephropathy)

Obinutuzumab in patients with pure class V lupus nephritis (systemic lupus erythematosus membranous nephropathy) – phase II trial

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What is this study about?

The study focuses on adults with systemic lupus erythematosus pure membranous nephropathy, a condition where the body’s immune system attacks the kidneys, causing a thickening of the filtering membrane and leading to protein loss in the urine. The investigational medication is obinutuzumab, which is given as a sterile liquid that is delivered into a vein (an infusion) over a short period. The drug is intended to target specific immune cells that contribute to kidney damage.

The purpose of the study is to determine whether a single course of the medication can help patients achieve a complete renal response, meaning the kidneys return to normal function according to international guidelines, one year after the first dose. Participants will receive the infusion at the start of the trial and will be monitored regularly with clinic visits, blood and urine tests, and questionnaires about daily living. Throughout the 52‑week follow‑up, researchers will record any side effects, track the need for additional medicines such as corticosteroids, and assess overall quality of life.

1 initial visit and baseline assessments

after joining the study, you will attend an initial clinic visit where basic health information is recorded.

blood and urine samples are taken to confirm the diagnosis of systemic lupus erythematosus pure membranous nephropathy and to establish baseline kidney function.

a review of any current medications, including corticosteroids, is performed.

2 first obinutuzumab infusion

you will receive a single dose of obinutuzumab 1000 mg, prepared as a solution for infusion and administered through a vein (intravenous infusion).

the infusion is given in a clinical setting where vital signs are monitored before, during, and after the procedure.

obinutuzumab is the active substance being tested; it belongs to a class of medicines called monoclonal antibodies.

3 regular follow‑up visits and safety monitoring

after the first infusion, you will return to the clinic at scheduled intervals for up to 52 weeks.

at each visit, blood and urine tests are repeated to track kidney function and to detect any changes in disease activity.

your healthcare team will ask about any side effects, including infections, low white‑blood‑cell counts (neutropenia), new cancers, or reactions related to the infusion.

all reported events are recorded as adverse events.

4 assessment of renal response at week 52

at week 52 after the first obinutuzumab infusion, a comprehensive evaluation is performed to determine whether a complete renal response has been achieved.

complete renal response is defined by the 2024 international KDIGO guidelines as a specific level of kidney function without any intervening health events.

5 evaluation of additional outcomes

during the week‑52 visit, the study also measures whether you have reached immunologic remission, which means normal complement protein levels (c3 and c4) and a negative anti‑dsdna test.

the proportion of time you are free from corticosteroids is recorded.

your quality of life is assessed using a standardized questionnaire.

6 study completion

after the week‑52 assessments, the trial period for you ends.

all collected data are compiled for analysis, and you will be informed that your participation in the study is concluded.

Who Can Join the Study?

Age: You must be between 18 and 75 years old.
Systemic lupus erythematosus (SLE): You need a diagnosis of SLE that meets the 2019 EULAR/ACR classification criteria (a scoring system where a score of 10 or higher confirms the disease).
Pure class V lupus nephritis: This is a specific type of kidney involvement caused by SLE. It must be confirmed by a kidney (renal) biopsy that follows the ISN/RPS 2003 classification guidelines (a system doctors use to describe kidney tissue findings).
Nephrotic range proteinuria or uncontrolled proteinuria: You must have either (a) a high amount of protein in your urine (more than 3 grams of protein per gram of creatinine) at the screening visit, or (b) persistent protein in the urine (more than 1 gram per gram of creatinine) even after at least three months of the best‑tolerated doses of an ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) together with an SGLT2 inhibitor (SGLT2i) and possibly a diuretic (medication that helps remove excess fluid).
Women of childbearing age: If you are a woman who could become pregnant, you must agree to either avoid heterosexual intercourse or use reliable birth control methods for at least 18 months after the last dose of the study drug (obinutuzumab).
Informed consent: You must sign a form showing that you understand the study and agree to take part.
French social security affiliation: You must be enrolled in the French social security system as a beneficiary or legal member.
Timing of kidney biopsy: The kidney biopsy that showed pure class V lupus nephritis must have been performed no more than 12 months before your baseline study visit.

Who Cannot Join the Study?

Currently receiving treatment for a severe type of lupus kidney disease called proliferative lupus nephritis (class III‑A or IV‑A).
Had any anti‑CD20 therapy (e.g., rituximab, ocrelizumab, ofatumumab) less than 6 months before screening or during screening; if it was given 6‑12 months ago, you must have a blood B‑cell count above 25 cells/µL.
Taken any of the following drugs within 2 months before screening or during screening: cyclophosphamide, tacrolimus, ciclosporin, mycophenolate mofetil, high‑dose pulse methylprednisolone, or voclosporin. (Low‑dose steroids under 10 mg/day prednisone are allowed.)
Received any other biologic medicine (such as belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept) within 2 months before screening or during screening.
Used oral inhibitors of JAK, BTK, or TYK2 (for example baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, fenebrutinib) or any investigational drug within 2 months before screening or during screening.
Received any live vaccine (a vaccine that contains a weakened form of the germ) within 28 days before screening or during screening.
Has a known medical reason (contraindication) that makes using obinutuzumab, its pre‑medication drugs, or its inactive ingredients unsafe, or you are allergic to any of them.
Kidney biopsy shows fewer than 10 healthy‑looking glomeruli (the tiny filtering units) that can be examined.
Are currently pregnant or breastfeeding.
Have an active infection that needs treatment (bacterial, viral, or fungal), including active hepatitis B (positive surface antigen with detectable viral DNA).
Have an unexplained fever.
Have a low neutrophil count (absolute neutrophil count < 1.5 × 10⁹/L) or other serious blood problems such as a platelet count < 100 × 10⁹/L.
Have a history of progressive multifocal leukoencephalopathy (PML) or unexplained neurological signs that could indicate PML.
Need a live attenuated vaccine that cannot be postponed until after your B‑cells have recovered.
Have chronic kidney disease stage 4 or 5, meaning an estimated kidney function (eGFR) less than 30 ml/min/1.73 m² measured twice three months apart.
Kidney biopsy shows more than 60 % of the glomeruli or tubulo‑interstitial tissue (the supportive kidney tissue) is scarred.
Had a previously documented kidney disease causing protein in the urine (> 0.3 g/g or > 0.3 g/day) more than one year before the diagnosis of pure class V lupus nephritis.
Have primary membranous nephropathy, identified by positive anti‑PLA2R antibodies in the blood or on the kidney tissue.
Are already enrolled in another interventional study or clinical trial.
Are under legal protection (such as tutorship or curatorship) or are deprived of freedom.
Test negative for antinuclear antibodies (ANA) at a level below 1/80 on an immunofluorescence test.
Have a severe lupus flare affecting organs outside the kidney (for example heart, brain, lungs, or gut) that requires high‑dose steroids (> 1 mg/kg/day).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
CHU De Martinique	Fort De France	France
Hospital Foch	Suresnes	France
Hopital Europeen Marseille	Marseille	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Apjpbaydda Pouyauao Hgeahgoi Dk Mkvgluxcc	Marseille	France
Cbauph Hmeqpmukxhi Roybxftg Ujoljrcirteku Dz Tnrlo	Tours	France
Cdmnhv Hvdaqfwduxy Rjehbvrf Dbaiusaakgzccp	Angers	France
Hcsrvttn Uyitqwgwhgixyk Sbbsolxxic &qeawkp Hummwym dg Hyxoiyabbet	STRASBOURG, Alsace	France
Cgbyxk Hwulgptlelb Imxmqtof Gynglegy	Montreuil	France
Cpldqx Hifdxafuxcx Uirqbjwuowayk Dp Dlujc	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	23.04.2026

Trial locations

Investigated Drugs:

Obinutuzumab

Obinutuzumab is a medication given by intravenous infusion. In this study it is being tested to see if it can help people with a type of kidney disease called pure class V lupus nephritis. The drug works by targeting certain immune cells that may be causing damage to the kidneys. Researchers will give participants a series of infusions and then check after one year to see if the kidneys have improved enough to meet the criteria for a complete renal response.

Investigated Diseases:

Systemic lupus erythematosus

Systemic lupus erythematosus pure membranous nephropathy – This condition is a type of lupus that mainly affects the kidneys, causing a thickening of the tiny filters that clean the blood. The thickened filters allow protein to leak into the urine, which can lead to swelling in the legs, ankles, or face. Over time, the amount of protein loss may increase, and the kidneys may become less able to remove waste from the body. The disease usually develops slowly, with symptoms gradually becoming more noticeable. Changes in urine appearance or swelling often signal that the condition is progressing.

Trial ID:

2024-519985-35-00

Protocol code:

APHP240937

Trial Phase:

Therapeutic exploratory (Phase II)

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Obinutuzumab in patients with pure class V lupus nephritis (systemic lupus erythematosus membranous nephropathy) – phase II trial

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?