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Study on Rituximab for Adults with Relapsing Steroid-Sensitive Nephrotic Syndrome

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
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What is this trial about?

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

This clinical trial is focused on studying a condition known as Nephrotic Syndrome, specifically the type that responds to steroid treatment and tends to come back, known as Relapsing Nephrotic Syndrome. This condition is often caused by issues with certain kidney cells called podocytes, which are important for filtering waste from the blood. The study will use a medication called Rituximab, which is a type of treatment known as a monoclonal antibody. This medication is given through an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to compare the effectiveness and safety of two different treatment plans using Rituximab for maintaining remission in adults with relapsing nephrotic syndrome. Participants in the study will be randomly assigned to one of the two treatment plans. The study will observe how long it takes for the nephrotic syndrome to return after starting the treatment. The trial will also look at other factors, such as the number of relapses over a period of 24 months, the amount of steroid medication needed, and any side effects experienced by participants.

Throughout the study, participants will receive regular check-ups to monitor their health and the progress of their condition. The study aims to provide valuable information on how to best manage relapsing nephrotic syndrome with Rituximab, potentially improving treatment outcomes for those affected by this condition. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This means agreeing to participate after understanding the study's purpose and procedures.
Eligibility is confirmed based on criteria such as age (at least 18 years) and a diagnosis of a specific kidney condition known as podocytopathy.
Step 2
Initial assessment
An initial assessment is conducted to ensure the disease is in at least partial remission. This involves checking protein levels in the urine to be below a certain threshold.
Current treatment with glucocorticoids or similar medications is reviewed to confirm ongoing management of the condition.
Step 3
Randomization
Participants are randomly assigned to one of two treatment groups. This process is called randomization and helps ensure the study's results are unbiased.
Step 4
Treatment administration
The treatment involves the administration of rituximab, a medication given through an intravenous infusion. This means the medication is delivered directly into a vein.
The specific regimen and frequency of rituximab administration are determined by the study protocol and may vary between the two groups.
Step 5
Monitoring and follow-up
Participants are monitored for any changes in their condition, specifically looking for signs of nephrotic syndrome relapse.
Regular follow-up visits are scheduled to assess the effectiveness and safety of the treatment. This includes tracking any side effects or adverse events.
Step 6
Completion of study
The study is expected to continue until November 2029, with participants being followed for up to 24 months after randomization.
The primary goal is to determine the time to the first relapse of nephrotic syndrome and compare the effectiveness of the two treatment regimens.

Who can join the trial?

9 criteria

Provide informed consent to participate in the study. This means you agree to join the study after understanding what it involves.
Be at least 18 years old.
check
Have a diagnosis of podocytopathy, which is a kidney condition likely caused by the immune system. This includes:
- A diagnosis of MCD (Minimal Change Disease) or FSGS (Focal Segmental Glomerulosclerosis), which are specific kidney diseases.
- A history of responding well to standard treatment with glucocorticoids (a type of steroid medication), meaning the nephrotic syndrome went away within 16 weeks of treatment.
- Exclusion of other causes for nephrotic syndrome.
- check
  Have a history of the disease coming back, meeting these criteria:
  - At least one previous return of nephrotic syndrome.
  - The last return of nephrotic syndrome happened within 2 years before joining the study, either during treatment with immune system-affecting drugs or within 6 months after stopping such treatment.
  - Be on ongoing treatment with drugs that affect the immune system to keep the disease from coming back, lasting at least 2 weeks and no more than 100 weeks after achieving partial or complete remission.
  - At the time of joining the study, have at least a partial remission of the disease, with proteinuria (protein in urine) less than 1.0 g/day, achieved with treatment using glucocorticoids or other similar medications.

Who cannot join the trial?

5 criteria

Patients who do not have idiopathic steroid-sensitive nephrotic syndrome cannot participate. This is a kidney condition that responds to steroid treatment.
Patients who are not within the age range of 3 to 4 years old cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Both male and female patients are eligible, so gender is not an exclusion factor.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.

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Verified sites

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

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
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Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, Poland
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Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

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Investigated drugs

Rituximab is a medication used in this clinical trial to help manage relapsing nephrotic syndrome in adults. It works by targeting specific cells in the immune system that are involved in causing the disease. The trial is comparing two different ways of using Rituximab to see which is more effective in preventing the return of symptoms.

Rituximab

What is already known about the treatment

Rituximab – Rituximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently well-established in medical literature and is used in various clinical settings. The main therapeutic indication for Rituximab in this trial is the treatment of idiopathic steroid-sensitive nephrotic syndrome, particularly in cases of relapsing nephrotic syndrome due to podocytopathies in adults. At the molecular level, Rituximab works by targeting and binding to a specific protein called CD20 found on the surface of certain immune cells, leading to their destruction. It is classified pharmacologically as a monoclonal antibody, which is a type of targeted therapy designed to interfere with specific pathways in disease processes.

Investigated diseases

Idiopathic Steroid-Sensitive Nephrotic Syndrome – This is a kidney disorder characterized by the kidneys leaking large amounts of protein into the urine, leading to swelling in various parts of the body. The term "idiopathic" indicates that the exact cause of the condition is unknown. It is termed "steroid-sensitive" because it typically responds well to treatment with steroid medications. The syndrome often presents with symptoms such as swelling around the eyes, feet, and abdomen, as well as foamy urine due to high protein levels. Over time, individuals may experience episodes of relapse and remission, where symptoms can reappear after a period of improvement. The condition is more common in children and can vary in frequency and severity of relapses.