Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of Rituximab, Prednisolone and Betamethasone in Adult Patients with First Episode of Minimal Change Nephrotic Syndrome to Prevent Disease Relapse

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on Minimal Change Nephrotic Syndrome, a kidney condition where proteins leak into urine, causing low protein levels in the blood and swelling in different parts of the body. The research examines the effectiveness of two medications: Rituximab (given through an intravenous infusion) and oral steroids (Prednisolone and Betamethasone) in treating adults experiencing their first episode of this condition.

The main purpose is to determine if using Rituximab, given as two separate infusions one week apart, along with a short course of steroids, can prevent the kidney condition from returning. The treatment involves receiving Rituximab through a vein while also taking steroid medications by mouth for 9 weeks. After the steroid treatment ends, patients continue to be monitored for signs that the condition has returned.

The study follows patients for 18 months to track how well the treatment works and to monitor any side effects that may occur. During this time, doctors regularly check protein levels in the blood and urine to see if the condition remains under control. They also collect information about how patients cope with the treatment and identify factors that might affect the likelihood of the condition returning.

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 phase

    You will receive oral prednisolone treatment as the initial therapy for Minimal Change Nephrotic Syndrome.

    The treatment continues until complete remission is achieved, which means your protein levels in urine return to normal range.

  2. Step 2

    Rituximab administration

    After achieving remission, you will receive two doses of rituximab (MabThera) through intravenous infusion.

    The doses are given one week apart, with each dose being 375mg per square meter of body surface.

    The medication is given as an infusion directly into your vein at the hospital.

  3. Step 3

    Steroid withdrawal phase

    Your steroid medication (prednisolone) will be gradually reduced over 9 weeks until complete withdrawal.

  4. Step 4

    Follow-up period

    Regular monitoring will continue for 12 months after starting the treatment.

    During this time, your kidney function will be checked through blood and urine tests.

    The main focus will be on checking if the nephrotic syndrome returns (relapse).

    Additional follow-up continues until 18 months after treatment initiation.

  5. Step 5

    Health monitoring

    Throughout the study, your health status will be monitored for any side effects.

    You will be asked to complete questionnaires about how the treatment affects your daily life.

    Regular medical examinations and laboratory tests will be conducted to monitor your health status.

Who can join the trial?

8 criteria

  • Must be 18 years or older
  • Must have either:
    • First episode of kidney condition with albumin levels below 30 g/L and urine protein/creatinine ratio of 300mg/mmol or higher, OR
    • Confirmed diagnosis through kidney biopsy showing minimal change in kidney tissue with specific microscopic findings
    • Must be willing and able to provide written informed consent to participate in the research study
    • Must be registered with the French healthcare system
    • Can be either male or female
    • Must not be part of a vulnerable population group
    • Must be able to receive treatment with Rituximab (a medication given through intravenous infusion)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with Rituximab (a type of medication that affects the immune system)
  • Pregnancy or breastfeeding
  • Active or chronic infection, including:
    • Hepatitis B (liver infection)
    • Hepatitis C (liver infection)
    • HIV (human immunodeficiency virus)
    • Tuberculosis (bacterial infection affecting lungs)
    • Severe heart conditions
    • Severe liver disease
    • History of cancer in the past 5 years
    • Known allergies to Rituximab or similar medications
    • Participation in other clinical trials within the last 30 days
    • Mental conditions that could affect ability to provide informed consent
    • Inability to follow study procedures or attend follow-up visits
    • History of drug or alcohol abuse within the past year
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Rituximab

    is a medication that works by targeting specific cells in your immune system called B cells. It is commonly used to treat certain autoimmune conditions and some types of blood cancers. In this trial, it is being studied as a treatment for Minimal Change Nephrotic Syndrome (MCNS), a kidney condition that causes protein loss in urine. The medication is given through an intravenous infusion (directly into the vein) and is being tested to see if it can prevent the disease from coming back after initial treatment.

  • Steroids

    are medications that help reduce inflammation and suppress the immune system. In this trial, they are used as part of the initial treatment for MCNS, and the researchers are studying how to gradually stop steroid treatment while using Rituximab to prevent the disease from returning.

What is already known about the treatment

Rituximab - A targeted biological medication administered through intravenous infusion, typically given as two doses of 375mg/m² one week apart. This monoclonal antibody belongs to the class of immunosuppressive agents and works by targeting and reducing B-cells in the immune system, which play a role in various autoimmune conditions. It is currently used in treating Minimal Change Nephrotic Syndrome (MCNS) in adults, as well as various autoimmune disorders and certain types of blood cancers. The medication works at the molecular level by binding to the CD20 protein found on B-cells, leading to their destruction and thereby reducing the immune system's overactivity that contributes to disease symptoms.

Investigated diseases

Minimal Change Nephrotic Syndrome - A kidney condition characterized by excessive protein loss in urine, leading to low protein levels in blood and swelling in various parts of the body. The disease gets its name because kidney tissue appears nearly normal under a regular microscope, showing only minimal changes when examined with an electron microscope. The condition causes the tiny filters in the kidneys (glomeruli) to become more permeable, allowing proteins to leak from blood into urine. It commonly results in significant swelling (edema), particularly around the eyes, feet, and ankles. The condition can occur as single episodes or may follow a relapsing-remitting pattern over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516102-36-00Protocol codeP170922JEstimated enrolment148 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.