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Obinutuzumab treatment for adults with frequently relapsing idiopathic nephrotic syndrome who are dependent on rituximab

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What is this trial about?

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

This study focuses on individuals with Idiopathic Nephrotic Syndrome, a rare condition where the kidneys leak too much protein into the urine, which can cause swelling in the body. The research specifically looks at patients whose condition frequently returns and who have previously relied on rituximab. The purpose of the study is to evaluate if the drug obinutuzumab can help keep the disease in remission, meaning a period where the symptoms are controlled, for at least 12 months.

Participants will receive obinutuzumab through an infusion, which is a method of delivering medication directly into a vein. This treatment is administered once the patient reaches remission using steroid therapy. During the course of the study, health changes will be monitored, including levels of protein and albumin in the blood and urine, as well as kidney function through iohexol plasma clearance, a technique used to measure how well the kidneys filter the blood.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment initiation</b>

    After remission, which is a period when the symptoms of idiopathic nephrotic syndrome (a condition affecting the kidneys) are under control through steroid treatment, obinutuzumab is administered.

    obinutuzumab is provided as a solution for infusion, which means it is delivered into the bloodstream through a tube over a period of time.

  2. Step 2

    <b>monitoring and measurements</b>

    At 6 months and 12 months after the start of the treatment, measurements are taken to check kidney function using a technique called iohexol plasma clearance.

    This process involves an injection of iohexol, which is a solution for injection, to help evaluate how well the kidneys are working.

  3. Step 3

    <b>long-term observation</b>

    The progress is monitored to see if the condition remains in remission for at least 12 months without a relapse.

    Various health indicators are tracked, including protein levels in the urine, blood levels of cholesterol and proteins, weight, and kidney filtration rates.

Who can join the trial?

11 criteria

  • You must be an adult, which means you are 18 years of age or older.
  • You must have a confirmed diagnosis of Idiopathic Nephrotic Syndrome, a condition where the kidneys allow too much protein to leak into the urine, based on a kidney biopsy performed within the last 5 years. A biopsy is a medical procedure where a small piece of tissue is removed from the body to be examined under a microscope.
  • The biopsy must show specific types of kidney damage, such as Minimal Change Disease (MCD), Focal Segmental Glomerulosclerosis (FSGS), or IgM glomerulonephritis, which are specific ways the filtering units of the kidney can be damaged.
  • You must have a history of relapsing nephrotic syndrome, meaning your symptoms have returned multiple times after initially improving with steroids (medicines used to reduce inflammation).
  • You must have experienced a relapse (a return of the disease) within 12 months after stopping a preventive treatment called rituximab. A relapse in this study is defined by high levels of protein in the urine and low levels of albumin (a protein in the blood) in your blood test results.
  • Your Estimated GFR (a measure of how well your kidneys are filtering waste from your blood) must be 30 or higher.
  • You must be able to understand the study details and provide written consent, which is a formal signed agreement to participate.
  • You must agree to use effective contraception (methods to prevent pregnancy) without interruption from 28 days before starting the treatment until 18 months after finishing it.
  • Male participants must agree not to donate semen during the treatment and for 18 months after finishing the treatment.
  • Female participants must stop breastfeeding during the treatment and for 18 months after the last dose of obinutuzumab (the study medication).
  • Female participants must agree to have pregnancy tests at specific times during the study.

Who cannot join the trial?

18 criteria

  • Having an active or recent history (within the last 5 years) of malignancy, which is a term for cancer.
  • Having other active systemic immune diseases, which are conditions where the body's immune system attacks its own healthy tissues, that require treatment with steroids or other immunosuppressive agents (medicines that lower the body's immune response).
  • Having severe or unstable heart failure that requires staying in the hospital or changing heart medications.
  • Having refractory severe hypertension, which is very high blood pressure that does not improve even after taking at least three different blood pressure medications.
  • Having a severe infection within the last 4 weeks that required hospital care or intravenous antibiotics (medicine given directly into a vein).
  • Having a known infection with the human immunodeficiency virus (HIV).
  • Having a history of Hepatitis B infection if you test positive for certain markers of the virus, unless you show signs of having naturally cleared the infection.
  • Having an untreated or not fully cured Hepatitis C (HCV) infection.
  • Planning to receive a live virus vaccine.
  • Having any active infections caused by bacteria, viruses, or fungi.
  • Having a history of drug or alcohol abuse.
  • Being pregnant, breastfeeding, or planning to become pregnant during the study or up to 18 months after the last dose of the study medicine.
  • Planning to donate eggs or sperm during the study period.
  • Being able to have children but not using highly effective contraception (methods to prevent pregnancy).
  • Having a known hypersensitivity, which is an allergic reaction, to the active ingredient or any of the other ingredients in the study drug.
  • Being unable to fully understand the potential risks and benefits of participating in the study.
  • Participating in another clinical trial involving a new test medicine within the last month.
  • Having any other serious medical condition or laboratory abnormality (unusual results from blood or urine tests) that makes it unsafe to participate.
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Investigated drugs

Obinutuzumab is a medication given through an infusion into a vein. It is used in this study to see if it can help keep patients in remission and prevent the disease from coming back after they have reached a stable state with steroid treatment.

What is already known about the treatment

  • Obinutuzumab

    This medication is an injectable solution that is administered into a vein through a process called an infusion. It is currently used as a specialized treatment for certain types of blood-related diseases and is being studied for its effectiveness in managing kidney issues like idiopathic nephrotic syndrome. At a molecular level, it works by specifically attaching to certain proteins on the surface of immune cells to help the body eliminate them. It is classified as a targeted biological therapy designed to calm an overactive immune system.

  • Iohexol

    This substance is an injectable liquid used primarily as a contrast agent to help doctors see internal organs more clearly during medical imaging tests. It is a well-established tool in medical practice used to improve the quality of X-rays or CT scans. The medication works by temporarily changing how certain body tissues interact with radiation, making them appear brighter on a scan. It is pharmacologically classified as a radiopaque contrast medium.

Investigated diseases

Idiopathic Nephrotic Syndrome - This condition occurs when the filters in the kidneys, called glomeruli, allow too much protein to leak from the blood into the urine. The exact cause of this leakage is unknown. As the disease progresses, the loss of protein in the urine can lead to low levels of protein in the blood. This imbalance often results in swelling, particularly in the legs, ankles, and around the eyes. The condition may involve periods of stability followed by sudden flare-ups where symptoms worsen.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523306-33-00Estimated enrolment10 patientsSponsorIstituto Di Ricerche Farmacologiche Mario Negri

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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).