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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Stichting Radboud University Medical Center	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Obinutuzumab

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.

Investigated diseases:

Glomerulonephritis membranous

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 ID:

2025-521139-35-01

Protocol code:

2025-521139-35-01

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?