Study on Early Rituximab Treatment for Children with Nephrotic Syndrome

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What is this study about?

This clinical trial is focused on studying the effects of early treatment with rituximab in children who have idiopathic nephrotic syndrome. Nephrotic syndrome is a kidney disorder that causes the body to excrete too much protein in the urine. The study aims to assess how long the disease stays in remission, which means the symptoms are reduced or disappear, in children receiving rituximab compared to those receiving a placebo. Rituximab is a medication that is given as an infusion, which means it is administered directly into the bloodstream through a vein.

Participants in the study will receive either rituximab or a placebo. The study will monitor the participants over a period to see how long they remain free from relapses, which are episodes when the symptoms of nephrotic syndrome return. The study will also look at other factors, such as the time it takes for treatment to fail and the total amount of steroids used by the participants. Steroids are often used to treat nephrotic syndrome, but they can have side effects, so finding ways to reduce their use is important.

The trial will follow participants for a year to gather information on how effective rituximab is in maintaining remission and reducing the need for steroids. This information could help improve treatment strategies for children with nephrotic syndrome, potentially leading to better long-term outcomes and quality of life for those affected by this condition.

1 signing consent

Express willingness to participate in the study. After receiving information about the study, sign an informed consent form. If you are under 18, your legal guardians will sign the form on your behalf.

2 eligibility confirmation

Ensure you meet the criteria for participation. You must be between 2 and 16 years old and have a diagnosis of idiopathic steroid-dependent nephrotic syndrome or nephrotic syndrome with frequent relapses. You must be in remission of nephrotic syndrome immediately before entering the study.

3 pregnancy test

If you are of childbearing age, a pregnancy test will be conducted to confirm a negative result before starting treatment. Commitment to abstinence or effective contraception is required during the study and up to 12 months after stopping treatment.

4 treatment phase

Receive the investigational drug, rituximab, administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

5 observation period

Participate in a blinded phase lasting up to 365 days, during which your health and response to the treatment will be monitored. The primary goal is to assess relapse-free survival, defined as the absence of protein in the urine for three or more days.

6 follow-up

Continue to be monitored for any relapses or treatment failures. The total dose of administered steroids and the time from depletion resolution to relapse will be recorded.

Who Can Join the Study?

The patient or their legal guardians must express willingness to participate in the study and sign a form that shows they understand the study and agree to take part.
The patient must be older than 2 years (more than 24 months) and younger than 16 years.
The patient must have a diagnosis of idiopathic steroid-dependent nephrotic syndrome (this means having two relapses when reducing steroid medication or within two weeks after stopping it) or nephrotic syndrome with frequent relapses (this means having two or more relapses in 6 months while on steroid medication or four or more relapses in 12 months).
The patient must be in remission from nephrotic syndrome right before starting the study. Remission means having little or no protein in the urine for 3 days in a row, as shown by specific urine tests.
Patients who can have children must agree to avoid pregnancy by not having sex or using effective birth control during the study and for 12 months after stopping the study medication. Girls who can become pregnant must have a negative pregnancy test before starting the treatment.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who are unable to follow the study procedures or instructions.
Patients with a known allergy to the study medication or its ingredients.
Patients with a history of drug or alcohol abuse within the past year.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.
Patients with a history of heart attack or stroke within the last 6 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Dzieciecy W Lublinie	Lublin	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland
Mciqypm Uyqvtszmer Oa Gwjdvi	Gdansk	Poland
Mhrunrg Uognfwkfvy Oy Byqnjhhbi	Bialystok	Poland
Svpyrig Kjhkmgpjs Ics Kuawen Jyfyfaexx Ueyyhbkgybht Mzyloddmaz Ilz Kqmxqj Mefolidctlbakyi W Pinuftnw	Poznan	Poland
Smzlpkdoaef Peyybfbjl Svlmxuc Kujypapru Nt 1 Ijucvfdnjrbgvzbvir Sjelcdl Sqircmdap Ugzggztpmtyu Mimwfemlch W Kzkzktdaed	Zabrze	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.12.2021

Trial locations

Investigated drugs:

Rituximab

Rituximab is a medication used in this clinical trial to treat children with a condition called idiopathic nephrotic syndrome. This condition affects the kidneys and can cause them to leak protein into the urine. Rituximab works by targeting specific cells in the immune system that may be causing the kidneys to malfunction. By doing this, it helps to reduce the symptoms of the disease and can lead to longer periods without symptoms, known as remission. The goal of using rituximab in this trial is to see if it can help children stay in remission longer compared to those who do not receive the medication.

Investigated diseases:

Nephrotic syndrome

Nephrotic Syndrome – Nephrotic Syndrome is a kidney disorder characterized by excessive protein loss in the urine, leading to low protein levels in the blood. This condition results in swelling, particularly in the legs and around the eyes, due to fluid retention. The disease progresses as the kidneys become increasingly unable to filter waste and excess water from the blood. Over time, this can lead to further complications such as high cholesterol levels and increased risk of infections. The syndrome can occur at any age but is most common in children. It often involves periods of remission and relapse, where symptoms may temporarily improve before returning.

Trial ID:

2024-515058-26-00

Protocol code:

NBK155/1/2020

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Early Rituximab Treatment for Children with Nephrotic Syndrome

What is this study about?

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