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Study of obinutuzumab to reduce PLA2R antibodies in patients with primary membranous nephropathy

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What is this trial about?

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

This clinical trial focuses on patients with primary membranous nephropathy, a kidney disease where the body's immune system attacks the filtering membranes in the kidneys, causing protein loss in urine. The study investigates the use of obinutuzumab (also known as Gazyvaro), a medication that is given through an intravenous infusion. This medicine belongs to a group of drugs that target specific proteins in the immune system.

The purpose of the study is to understand how quickly certain antibodies (called PLA2R antibodies) disappear from the blood after treatment with obinutuzumab. Patients will receive a total of 4000 mg of the medication, administered as 1000 mg doses. The treatment period lasts for approximately 12 months, during which regular blood tests will be performed to measure antibody levels.

Throughout the study, doctors will monitor how well the treatment works by checking protein levels in urine and blood. They will also track the patients' overall health and quality of life. The medication will be given in a healthcare setting where medical professionals can monitor for any side effects during and after the infusion.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment with obinutuzumab

    You will receive Gazyvaro (obinutuzumab) through an intravenous infusion (delivered directly into your vein)

    The medication dose is 1,000 mg of obinutuzumab in the form of a solution for infusion

  2. Step 2

    Blood tests schedule

    Your blood will be tested to measure PLA2R antibody levels at specific intervals:

    Initial test before starting treatment (baseline)

    Follow-up tests at weeks 1, 2, 4, 8, 12, 24, 37, and 52 after receiving the infusions

  3. Step 3

    Regular monitoring

    Your kidney function will be regularly monitored through blood and urine tests

    The medical team will track your protein levels in urine and serum albumin (a type of protein in blood)

    Your overall health status and any potential side effects will be monitored throughout the study period

  4. Step 4

    Quality of life assessment

    You will be asked to complete questionnaires about your well-being during the treatment period

    These assessments help evaluate how the treatment affects your daily life

  5. Step 5

    Final evaluation

    At 12 months, your response to treatment will be evaluated

    The medical team will assess whether you have achieved clinical remission (improvement in kidney function and reduction in protein loss)

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have confirmed primary membranous nephropathy through either: - A kidney biopsy, or - A positive blood test for anti-PLA2R antibodies
  • Blood test must show anti-PLA2R antibody levels higher than 80 RU/ml
  • Must have protein in urine of 3.5 grams or more per day despite taking blood pressure medications (ACE-inhibitors or ARBs) for at least 6 months
  • Blood test must show albumin levels less than 30 grams per liter (albumin is a protein made by the liver)
  • Must have kidney function (eGFR) of 30 ml/min/1.73m2 or better
  • Doctor must determine that immune system treatment is necessary for the patient's condition

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with rituximab (a type of antibody therapy) in the last 12 months
  • Active infection requiring treatment
  • History of hepatitis B or C infection
  • Active tuberculosis infection
  • Known HIV infection
  • Pregnancy or breastfeeding
  • Severe heart, lung, or liver disease
  • Active cancer or history of cancer in the past 5 years
  • History of severe allergic reactions to biological medications
  • Participation in other clinical trials within the last 30 days
  • Mental conditions that prevent understanding of the study requirements
  • Low blood cell counts (leukopenia, thrombocytopenia, anemia)
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
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Investigated drugs

Obinutuzumab is a medication that belongs to a class of drugs called monoclonal antibodies. It works by targeting specific proteins in the body's immune system. This medication is given through an intravenous infusion (directly into the vein) and is being studied for its ability to reduce certain antibodies (called PLA2R antibodies) in patients with membranous nephropathy, a kidney condition. The medication aims to modify the immune system's response to help treat the underlying disease.

What is already known about the treatment

Obinutuzumab - A monoclonal antibody medication administered through intravenous infusion that is used in the treatment of primary membranous nephropathy, a kidney disease characterized by immune system attacks on the kidney's filtering membranes. This targeted therapy works by binding to and depleting B-cells that produce harmful antibodies against PLA2R (phospholipase A2 receptor) proteins in the kidney. As a biological therapy classified as a CD20-directed cytolytic antibody, Obinutuzumab represents an innovative approach in treating autoimmune kidney conditions by specifically modulating the immune response rather than using broad immunosuppression.

Investigated diseases

Primary Membranous Nephropathy - A kidney disease that affects the glomeruli, which are the tiny filtering units in the kidneys. It occurs when antibodies attack specific proteins in the kidney's filtering membranes, causing them to thicken and become damaged. The condition develops gradually and leads to protein leakage from blood into urine. Primary membranous nephropathy mainly affects adults and develops without any obvious underlying cause. The disease typically causes swelling in the legs and ankles, and may lead to high blood pressure and changes in kidney function over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521139-35-01Protocol code2025-521139-35-01Estimated enrolment20 patientsSponsorStichting Radboud universitair medisch centrum

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