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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Centre Hospitalier Universitaire De Nimes Nimes France
Hospital Edouard Herriot Lyon France
Pellegrin Hospital Bordeaux France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Ajrcgmunyl Pbvymdzu Hharqkar Ds Mbqgwivqm Marseille France
Btzjfrqo Uexdeqtdmb Hxuwkqur Chmyqh Besançon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.10.2024

Trial locations

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.

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 ID:
2024-510718-34-00
Protocol code:
22-APN-01
NCT ID:
NCT06341205
Trial Phase:
Human Pharmacology (Phase I) – Other

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