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Study on the Effectiveness and Safety of Obinutuzumab and Mycophenolate Mofetil in Children with Idiopathic Nephrotic Syndrome

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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 Childhood Idiopathic Nephrotic Syndrome. This is a kidney disorder that often occurs in children and is characterized by the kidneys leaking protein into the urine, leading to swelling and other symptoms. The study is comparing the effectiveness and safety of two treatments: Obinutuzumab and Mycophenolate Mofetil (also known as MMF). Obinutuzumab is a medication given through an intravenous infusion, which means it is administered directly into a vein. Mycophenolate Mofetil is available in two forms: as a powder for oral suspension and as film-coated tablets, both of which are taken by mouth.

The purpose of this study is to evaluate how well Obinutuzumab works compared to MMF in treating children with this kidney condition. Participants in the study will receive either Obinutuzumab or MMF and will be monitored over a period of time to see how their condition responds to the treatment. The study will look at various outcomes, such as the percentage of participants who achieve sustained complete remission, which means their symptoms are fully controlled for a certain period. Other aspects being studied include the number of relapses, the overall survival without relapses, and the amount of corticosteroids used during the treatment period.

Throughout the study, researchers will also monitor the participants for any side effects or changes in their health. This includes checking for any adverse events, which are unexpected medical problems that may occur during the study. The study aims to provide valuable information on the best treatment options for children with Childhood Idiopathic Nephrotic Syndrome, helping to improve their quality of life and manage their condition more effectively.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome before the age of 18.

    The patient must be in complete remission, which means no swelling and specific urine protein levels, and must have had at least one relapse in the past six months.

  2. Step 2

    Randomization

    The patient is randomly assigned to receive either obinutuzumab or mycophenolate mofetil (MMF) as part of the study treatment.

  3. Step 3

    Treatment phase

    If assigned to obinutuzumab, the patient receives it as an intravenous infusion. The specific schedule and dosage are determined by the study protocol.

    If assigned to MMF, the patient takes it orally. It is available as a powder for oral suspension or as film-coated tablets. The dosage and frequency are specified by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the patient's health and response to treatment. This includes checking for sustained complete remission at one year and other health indicators.

    The study also tracks the overall relapse-free survival, the probability of relapse-free survival at week 52, and the cumulative corticosteroid dose.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the percentage of participants with sustained complete remission at one year.

    Secondary outcomes include the number of relapses, changes in fatigue and physical functioning, and the incidence of adverse events.

  6. Step 6

    End of study

    The study is estimated to conclude by August 15, 2026. At this point, final assessments are made to evaluate the efficacy and safety of the treatments.

Who can join the trial?

5 criteria

  • Must have been diagnosed with frequently relapsing nephrotic syndrome (FRNS) or steroid dependent nephrotic syndrome (SDNS) before turning 18 years old. These are conditions where the kidneys leak too much protein into the urine.
  • Must be in complete remission, which means no swelling (edema), a urine protein-to-creatinine ratio (UPCR) of 0.2 grams per gram or less at the start of the study, and three daily urine tests in a row showing trace or no protein in the week before joining the study.
  • Must have had at least one relapse in the 6 months before the study starts, either after stopping or while taking oral corticosteroids or other medicines to prevent relapses. A relapse is when symptoms return after a period of improvement.
  • If the participant received cyclophosphamide (a type of medication) in the 6 months before joining the study, they must have had at least one relapse after stopping cyclophosphamide.
  • Must have an estimated glomerular filtration rate (eGFR) within the normal range for their age. eGFR is a test that checks how well the kidneys are working.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent infection that could affect their health.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain treatments recently that could interfere with the study.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a recent surgery or are planning to have surgery during the study.
  • Patients with a history of certain types of cancer.
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Investigated drugs

  • Obinutuzumab

    is a medication used in this trial to treat patients with childhood onset idiopathic nephrotic syndrome. It is a type of drug known as a monoclonal antibody, which works by targeting specific cells in the immune system to help reduce inflammation and prevent kidney damage.

  • MMF

    , or Mycophenolate Mofetil, is another medication being tested in this trial. It is an immunosuppressant, which means it helps to lower the body's immune response. This can be beneficial in conditions like nephrotic syndrome, where the immune system is overactive and causes harm to the kidneys.

What is already known about the treatment

  • Obinutuzumab

    This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating childhood idiopathic nephrotic syndrome. Obinutuzumab is primarily used for certain types of blood cancers, but its potential in other conditions is being explored. It works by targeting a specific protein on the surface of certain immune cells, leading to their destruction. Obinutuzumab is classified as a monoclonal antibody.

  • Mycophenolate Mofetil (MMF)

    This medication is taken orally, usually in the form of a tablet or capsule. It is well-established in medical practice and literature for its use in preventing organ rejection in transplant patients and is being evaluated for childhood idiopathic nephrotic syndrome. MMF works by inhibiting an enzyme necessary for the growth of certain immune cells, thereby reducing immune system activity. It is classified as an immunosuppressant.

Investigated diseases

Childhood Idiopathic Nephrotic Syndrome – This is a kidney disorder that primarily affects children, characterized by the kidneys leaking large amounts of protein into the urine. The condition often leads to swelling in various parts of the body, particularly around the eyes, ankles, and abdomen. It is termed "idiopathic" because the exact cause is unknown, although it is believed to involve an immune system malfunction. The syndrome typically presents with symptoms such as foamy urine, fatigue, and weight gain due to fluid retention. Over time, children may experience periods of remission and relapse, where symptoms improve and then return. The progression of the disease can vary, with some children experiencing frequent relapses while others may have long periods without symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505140-19-00Protocol codeWA43380Estimated enrolment80 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).