Study on Rituximab Treatment for Children with Complicated Steroid-Sensitive Nephrotic Syndrome

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What is this study about?

This clinical trial is focused on studying a condition known as steroid-sensitive nephrotic syndrome (SSNS), specifically its complicated forms in children. SSNS is a kidney disorder that causes the body to release too much protein in the urine. The study will use a treatment called Rixathon, which contains the active substance rituximab. Rituximab is a type of protein used to help manage certain immune system conditions. The purpose of the study is to determine the best way to use rituximab in treating children with complicated forms of SSNS.

Participants in the study will receive rituximab as a solution for infusion, which means it will be administered directly into the bloodstream through a vein. The study will compare two different treatment plans to see which is more effective. One plan will focus on the reconstitution of total B cells, which are a type of white blood cell important for the immune system, while the other will focus on memory B cells, which help the body remember how to fight infections. The study will last for up to 24 months, during which time the number of rituximab infusions needed will be evaluated.

Throughout the study, researchers will monitor several factors, including the number of relapses, which is when symptoms return, the number of days participants spend in the hospital, and the occurrence of severe infections. They will also assess how long it takes for a relapse to occur after treatment. Additionally, the study will explore the levels of certain antibodies in the blood, which are proteins that help fight infections, and check for any prolonged low levels of these antibodies, which might require additional treatment. The study aims to provide valuable information on how to best use rituximab for children with complicated SSNS.

1 initial consent and information

Before starting the trial, it is necessary to provide written consent. If you are an adult, you will sign the consent form. If you are a child or adolescent, your parents or legal guardians will sign it. You will also receive information appropriate for your age to understand the study.

2 eligibility confirmation

Eligibility for the trial is confirmed based on specific criteria. You must be between 3 and 24 years old and have a complicated form of steroid-sensitive nephrotic syndrome. You should have experienced at least two relapses per year while on certain medications. Previous treatments with rituximab are allowed.

3 treatment administration

The treatment involves receiving Rixathon, which is a concentrate for solution for infusion. The dosage and frequency of administration will depend on the specific regimen you are assigned to. The trial compares two different regimens based on the reconstitution of B cells.

4 follow-up and monitoring

Throughout the trial, which lasts for 24 months, regular follow-up visits will be scheduled. During these visits, the number of relapses, hospitalization days, and any severe infections will be assessed. Blood tests may be conducted to evaluate immunoglobulin levels and antibody responses.

5 end of trial

At the end of the trial, a final assessment will be conducted to evaluate the outcomes of the treatment. This includes the number of rituximab re-infusions and the overall health status.

Who Can Join the Study?

Before any study procedures, a written agreement to participate must be obtained from the adult patient or from both parents/legal guardians of the child. For teenagers and school-aged children, agreement will be obtained with information suitable for their age.
Children and young adults aged 3 to 24 years with complicated forms of frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS) can participate. These are conditions where the kidneys leak too much protein into the urine.
Participants must have at least 2 relapses per year while taking mycophenolate mofetil (MMF) and/or a calcineurin inhibitor at appropriate doses. These are medications used to treat the condition.
Previous treatments with rituximab (RTX), a medication used to treat certain autoimmune diseases, are allowed.
Participants, if they are adults, and parents or legal guardians if they are minors, must be able to communicate well with the medical team and understand and follow the necessary procedures for the study.
For female participants who can have children, a reliable method of birth control (such as not having sex, using barrier methods like condoms, or hormonal birth control) must be used for the entire time they are in the study.

Who Cannot Join the Study?

Patients with any other serious health conditions that could interfere with the study.
Patients who have had an allergic reaction to the study medication or similar medications in the past.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain medications recently that could affect the study results.
Patients with a compromised immune system, which means their body’s defense against infections is weakened.
Patients who have had a recent infection that required treatment with antibiotics.
Patients with a history of cancer, unless it was a type that is not expected to come back.
Patients who have had a major surgery recently.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.11.2024

Trial locations

Investigated drugs:

Rituximab

Rixathon is a medication used in this clinical trial. It is a type of drug known as a monoclonal antibody. Rixathon works by targeting specific cells in the immune system called B cells. In this study, it is used to help manage a condition in children known as steroid-sensitive nephrotic syndrome, which affects the kidneys. The trial aims to find the best way to use Rixathon by comparing two different treatment plans. One plan is based on the total number of B cells, and the other is based on a specific type of B cell called memory B cells. The goal is to determine how often children need to receive Rixathon to effectively manage their condition.

Investigated diseases:

Nephrotic syndrome

Idiopathic Steroid-Sensitive Nephrotic Syndrome (SSNS) – This condition is characterized by the kidneys leaking large amounts of protein into the urine, leading to swelling in various parts of the body. It is termed “idiopathic” because the exact cause is unknown. The disease is “steroid-sensitive,” meaning that it typically responds well to steroid treatment, which reduces protein loss. Over time, some patients may experience frequent relapses, where symptoms return after initially improving. These relapses can lead to complications, such as infections or further kidney damage. The disease primarily affects children and can vary in severity and frequency of relapses.

Trial ID:

2024-511214-20-00

Protocol code:

MEM_01_OPBG_2024

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Rituximab Treatment for Children with Complicated Steroid-Sensitive Nephrotic Syndrome

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