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

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What is this study about?

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.

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 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 Steroid withdrawal phase

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

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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Cjvjbn Hkqgekkrjiq Inychplf Gufrxzws Montreuil France
Auhlzwstzq Pfafghps Hhnignao Dd Mobqohypv Marseille France
Crmufg Hlqwqigdyds Rvplgvyp Ukgbgrdnflytk Dq Tatna Tours France
Hjxhczlt Umopxkcowqkaxw Spevcqkfgw &xyowrl Hrcykky da Hyilujnoneu STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
29.07.2020

Trial locations

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.

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 ID:
2024-516102-36-00
Protocol code:
P170922J
NCT ID:
NCT03970577
Trial Phase:
Therapeutic exploratory (Phase II)

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