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Study of personalized rituximab dosing using artificial intelligence in patients with membranous nephropathy

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What is this trial about?

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

This study focuses on patients with membranous nephropathy, a kidney condition that causes protein loss in urine and low protein levels in blood. The study will test two different approaches for giving the medication rituximab, which is administered through intravenous infusion (given directly into a vein).

The purpose of this research is to compare two methods of giving rituximab treatment: a standard approach versus a personalized approach that uses artificial intelligence to determine the most appropriate dose for each patient. The personalized approach uses a computer algorithm to predict whether a patient might receive too little of the medication after three months of treatment.

During the study, patients will receive rituximab infusions over a period of 45 days. The maximum daily dose is 1 gram, with a total maximum dose of 4 grams during the treatment period. Patients will be monitored for changes in their kidney function and protein levels in their blood and urine. The study will track how well the treatment works for up to 12 months after the first dose of rituximab.

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 Treatment Phase

    You will receive Truxima (rituximab) through an intravenous infusion, which means the medication will be administered directly into your vein

    The treatment begins with your first infusion, marked as day 0

  2. Step 2

    Early Monitoring Period

    Blood samples will be collected on day 15, day 30, and day 45

    These samples will measure medication levels and other important indicators in your blood

  3. Step 3

    Three-Month Assessment

    At month 3, you will have a comprehensive evaluation

    This includes blood tests to check medication levels and kidney function

    Your protein levels in urine will be measured

  4. Step 4

    Six-Month Evaluation

    The month 6 check-up will assess your response to treatment

    Blood and urine tests will be performed to measure kidney function and treatment effectiveness

    Additional blood samples will be taken to analyze various immune system markers

  5. Step 5

    Nine-Month Follow-up

    At month 9, you will have routine blood tests

    Your kidney function and response to treatment will continue to be monitored

  6. Step 6

    Twelve-Month Final Assessment

    The month 12 visit marks the final evaluation period

    Complete assessment of your kidney function and treatment response will be performed

    Final blood and urine tests will be conducted to measure all relevant indicators

Who can join the trial?

10 criteria

  • Must be 18 years of age or older
  • Must have an ongoing case of membranous nephropathy confirmed by either:
    • Presence of specific antibodies (anti-PLA2R1 or anti-THSD7A) in blood, or
    • Kidney tissue examination (renal biopsy)
    • Must have nephrotic syndrome with:
      • Protein in urine greater than 3.5 grams per 24 hours, and
      • Blood albumin level less than 30 grams per liter
      • Must be eligible for rituximab treatment according to current medical guidelines
      • Must be on stable treatment for at least 2 weeks with:
        • Blood pressure medications
        • Water pills (diuretics)
        • Low-salt diet
        • Must have adequate kidney function with filtration rate above 30 milliliters per minute (as measured by CKD-EPI test)

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with rituximab (a type of medication that affects the immune system)
  • Presence of active infections, including but not limited to:
    • Hepatitis B (liver infection)
    • Hepatitis C (liver infection)
    • HIV (human immunodeficiency virus)
    • Tuberculosis (bacterial infection affecting lungs)
    • Severe heart conditions or uncontrolled high blood pressure
    • Active cancer or history of cancer in the past 5 years
    • Pregnancy or breastfeeding
    • Participation in other clinical trials within the past 30 days
    • Known allergies to rituximab or similar medications
    • Severe kidney dysfunction other than membranous nephropathy
    • Mental conditions that could affect the ability to provide informed consent
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Investigated drugs

Rituximab is a medication that works by targeting specific cells in your immune system called B cells. It's commonly used to treat certain autoimmune conditions, including membranous nephropathy, a kidney disease where the immune system attacks the kidneys. The medication is given through an intravenous infusion (through a vein) and helps reduce inflammation and damage to the kidneys by decreasing the number of harmful antibodies your body produces.

What is already known about the treatment

Rituximab - A targeted biological medication administered through intravenous infusion that belongs to the class of monoclonal antibodies. This drug works by specifically targeting and reducing B-lymphocytes (a type of white blood cell) that play a role in certain autoimmune conditions, including membranous nephropathy, a kidney disease. Rituximab has been well-established in medical literature and is currently used as a standard treatment option for various autoimmune disorders, with its effectiveness supported by numerous clinical studies and real-world evidence. The medication functions by binding to a specific protein called CD20 on the surface of B-cells, leading to their destruction and thereby reducing the immune system's attack on healthy tissues.

Investigated diseases

Membranous nephropathy - A kidney disease that affects the filtering membranes in the kidney's glomeruli, which are the tiny units that filter blood. The condition occurs when antibodies form deposits in the kidney's filtering membranes, causing them to thicken and become damaged. This thickening leads to protein leaking from the blood into the urine, a condition known as proteinuria. The disease typically develops slowly and gradually, often first noticed when protein in urine causes foamy urine. The condition can affect people of any age but is more common in adults over 40.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510718-34-00Protocol code22-APN-01Estimated enrolment130 patientsSponsorCentre Hospitalier Universitaire De Nice

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).