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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

22 criteria

  • 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).
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Investigated drugs

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.

What is already known about the treatment

Obinutuzumab - It is given by intravenous infusion as a clear solution that is mixed with fluid and delivered through a vein. The drug is already approved for treating some blood cancers such as chronic lymphocytic leukemia and follicular lymphoma, and it is now being studied for kidney involvement in systemic lupus erythematosus. It works by binding to a protein called CD20 on the surface of B‑cells, which helps the immune system remove these cells that contribute to disease. Obinutuzumab belongs to the class of anti‑CD20 monoclonal antibodies, a type of targeted immunotherapy.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519985-35-00Protocol codeAPHP240937Estimated enrolment65 patientsSponsorAssistance Publique Hopitaux De Paris

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