Study on Obinutuzumab vs. Rituximab for Children with Steroid-Dependent and Frequent Relapsing Nephrotic Syndrome

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What is this study about?

This clinical trial is focused on studying a condition known as Idiopathic Nephrotic Syndrome in children. This condition affects the kidneys and can lead to symptoms like swelling and protein in the urine. The study is comparing two treatments: Obinutuzumab and Rituximab. Both of these are medications given through an intravenous infusion, which means they are administered directly into a vein. The purpose of the study is to determine which medication is more effective in preventing relapses of the syndrome over a 12-month period.

Participants in the study will receive either Obinutuzumab or Rituximab and will be monitored for any relapses of their condition. The study will also look at how long the effects of the medications last, how many relapses occur, and any side effects that might happen, such as reactions to the infusion or infections. The study aims to provide valuable information on the safety and effectiveness of these treatments in managing Idiopathic Nephrotic Syndrome in children.

Throughout the study, researchers will also assess other factors, such as the cost-effectiveness of the treatments and the development of any antibodies against the drugs. The study is designed to help improve understanding of how these medications can be used to manage the condition and to potentially offer better treatment options for children affected by Idiopathic Nephrotic Syndrome.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age between 3 and 18 years, a history of steroid-dependent or frequently relapsing nephrotic syndrome, and recent remission status.

Informed consent from parents is required before participation.

2 randomization

Participants are randomly assigned to receive either obinutuzumab or rituximab through an intravenous infusion.

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment administration

Participants receive one infusion of the assigned medication, either obinutuzumab or rituximab.

The infusion is administered intravenously, meaning it is delivered directly into a vein.

4 monitoring period

Participants are monitored for a period of 12 months to assess the primary outcome, which is the occurrence of a relapse.

Relapse is defined as a specific level of protein in the urine over three consecutive days.

5 extended monitoring

Secondary outcomes are assessed over a 24-month period, including the comparison of relapse-free survival and the duration of B-cell depletion between the two treatments.

Safety assessments include monitoring for infusion-related reactions, infections, and changes in blood cell levels.

6 completion of study

The study is estimated to conclude by October 30, 2027.

Final assessments will include the evaluation of long-term outcomes and the cost-effectiveness of the treatments.

Who Can Join the Study?

The patient must be between the ages of 3 and 18 years old.
The patient must have a condition called Steroid Dependent Nephrotic Syndrome, which means they have had 2 or more relapses (return of symptoms) while on steroids or within 2 weeks after stopping them. Alternatively, they could have had 2 or more relapses, including one while on a medication that helps reduce the need for steroids, or within 6 months after stopping such treatment.
Another condition that qualifies is Frequent Relapsing Nephrotic Syndrome, which means having 2 or more relapses within 6 months after the first time the symptoms went away, or 3 or more relapses within any 12-month period.
The patient must have had their last relapse within 3 months before joining the study.
The patient must be in remission, which means having 3 consecutive urine tests that show no protein in the urine, at the time they are randomly assigned to a treatment group.
The patient must be up to date with their vaccinations according to the current recommendations in France.
The parents of the patient must provide informed consent, which means they agree to let their child participate in the study after understanding what it involves.

Who Cannot Join the Study?

Patients who have a different kidney condition other than Idiopathic Nephrotic Syndrome (INS). This is a kidney disorder that causes the body to lose too much protein in the urine.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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 Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Chnfta Hzzqmzwzzcw Rximlsfm Udhrieykwrjej Dd Tvvzj	Tours	France
Cwug Dy Nupfe	Vandoeuvre Les Nancy	France
Hmgunbzn Uyhfgxrrjotqig Srdozvoudv &hipvng Hewvqzo dj Hqrnlwdveqo	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	18.10.2023

Trial locations

Investigated drugs:

Obinutuzumab is a medication used in this trial to evaluate its effectiveness and safety in treating children with steroid-dependent and frequently relapsing nephrotic syndrome. It is given as an infusion and is being tested to see if it can help prevent relapses of the condition over a 12-month period.

Rituximab is another medication used in the trial for the same condition. Like obinutuzumab, it is administered as an infusion. The trial aims to compare rituximab’s ability to prevent relapses in children with nephrotic syndrome to that of obinutuzumab.

Investigated diseases:

Nephrotic syndrome

Idiopathic Nephrotic Syndrome – Idiopathic nephrotic syndrome is a kidney disorder characterized by excessive protein loss in the urine, leading to low levels of protein in the blood. This condition often results in swelling, particularly in the legs and around the eyes, due to fluid retention. The exact cause of idiopathic nephrotic syndrome is unknown, and it is not associated with any other identifiable kidney disease. The syndrome can lead to episodes of relapse and remission, where symptoms may improve and then return. It primarily affects children but can also occur in adults. The progression of the disease involves periods of increased proteinuria, which can fluctuate over time.

Trial ID:

2024-514240-93-00

Protocol code:

APHP 211038

NCT ID:

NCT05786768

Trial Phase:

Therapeutic use (Phase IV)

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Study on Obinutuzumab vs. Rituximab for Children with Steroid-Dependent and Frequent Relapsing Nephrotic Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?