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A study to evaluate the efficacy and safety of obinutuzumab compared to prednisolone in adults with newly onset minimal change disease

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What is this trial about?

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

This study aims to evaluate the effectiveness and safety of obinutuzumab in adults with newly diagnosed minimal change disease, a type of kidney disease. This condition involves damage to the filtering units of the kidney, which can lead to protein leaking into the urine. Participants in the study will receive either the study drug or a standard treatment consisting of prednisolone or prednisone, which are types of glucocorticoids used to reduce inflammation. Other medications that may be used as background therapy include rituximab and tacrolimus.

The study involves comparing the performance of obinutuzumab, which is given through an intravenous infusion, against the standard oral medication regimen. The standard treatment involves a gradual reduction of the medication dose over 24 weeks. Researchers will observe how many people achieve remission, which is a state where the signs and symptoms of the disease decrease or disappear, and how long they stay in this state without the disease returning.

During the study, various factors will be monitored, such as changes in kidney function and protein levels in the urine. The total duration of observation for participants is expected to last up to 52 weeks. This period allows for the assessment of how well the treatments work to manage the minimal change disease and to monitor for any potential side effects or changes in the body's ability to fight infections.

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

    Initial treatment phase

    Assignment to one of two treatment groups occurs upon joining the study.

    If assigned to the obinutuzumab group, an intravenous infusion (a liquid medicine delivered directly into a vein) of 1000 mg of obinutuzumab is administered.

    If assigned to the standard of care group, oral doses of 80 mg of prednisolone or betamethasone sodium phosphate (types of glucocorticoids, which are medicines used to reduce inflammation) are taken.

    Background medications, including 1000 mg of rituximab via intravenous infusion and 0.5 mg of tacrolimus taken orally, may be used as part of the underlying treatment regimen.

  2. Step 2

    Medication tapering

    For those in the standard of care group, the oral glucocorticoid doses are progressively tapered, meaning the amount of medicine is gradually reduced over a period of 24 weeks.

  3. Step 3

    Monitoring and follow-up

    The total duration of the study period is 52 weeks.

    Medical assessments are conducted to check for remission, which is a period where signs and symptoms of the minimal change disease (a type of kidney disease) decrease or disappear.

    Checks are performed to monitor kidney function, protein levels in the urine, and serum albumin (a protein in the blood).

    Safety is monitored throughout the 52 weeks to track any adverse events (side effects) or changes in immune system proteins.

Who can join the trial?

9 criteria

  • You must be able to understand the study rules and sign a document called informed consent, which means you officially agree to take part.
  • You must be at least 18 years old.
  • You must have a confirmed first episode of nephrotic syndrome, which is a condition where the kidneys leak too much protein into the urine.
  • This condition must be caused by minimal change disease (MCD), a specific type of kidney disorder that is seen under a microscope.
  • Your diagnosis of MCD must be confirmed through a biopsy, which is a procedure where a tiny piece of kidney tissue is removed to be examined.
  • Your blood tests must show serum albumin levels lower than 30g/l; serum albumin is a type of protein in your blood that keeps fluid from leaking out of your blood vessels.
  • Your urine tests must show a UPCR (urine protein-to-creatinine ratio) higher than 3g/g, which is a measurement used to check how much protein is being lost in your urine.
  • Women who are able to become pregnant must have a negative pregnancy test and agree to use contraception (methods to prevent pregnancy) for 18 months after their second treatment.
  • If you are participating at a site in France, you must be part of the French health care system.

Who cannot join the trial?

14 criteria

  • You cannot participate if your minimal change disease (a condition affecting the kidney filters) is caused by another issue, such as malignancy (cancer), or by certain medications like lithium, interferon, or non-steroidal anti-inflammatory drugs (common pain relievers).
  • You cannot join if you have or have had Hepatitis B, Hepatitis C, or HIV (a virus that affects the immune system), unless you are taking preventive medicine and the virus is not active in your body.
  • You cannot participate if you have had a severe infection requiring strong medicine to fight bacteria, fungi, or viruses within the 14 days before your first dose.
  • You cannot join if you have severe heart failure or uncontrolled heart problems, specifically those classified as NYHA class III or IV (levels indicating significant limitation in physical activity due to heart issues).
  • You cannot participate if you have had cancer within the last 5 years, though some very low-risk types may be allowed.
  • You cannot join if you are pregnant or currently breastfeeding.
  • You cannot participate if you have received a live vaccine (a type of vaccine that uses a weakened form of a germ) in the 4 weeks before the study or during the 52 weeks of the study.
  • You cannot join if you have a known hypersensitivity (an allergic reaction) to prednisolone, obinutuzumab, or any of the inactive ingredients used to make the medicine.
  • You cannot participate if you are already enrolled in another study testing a new medicine.
  • You cannot join if a close family member has minimal change disease, unless it was previously shown to respond well to steroids (medicines that reduce inflammation).
  • You cannot participate if you have had treatments that reduce B cells (a type of white blood cell that helps fight infection) within the last 12 to 18 months.
  • You cannot join if you have taken cyclophosphamide (a strong medicine used to treat cancer or immune issues) within the 6 months before the study begins.
  • You cannot participate if you have taken prednisolone (a steroid medicine) during the screening period before being assigned to the study.
  • You cannot join if the Principal Investigator (the main doctor in charge of the study) decides that you are not suitable for the trial for any other reason.
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Investigated drugs

  • Obinutuzumab

    is a medication given through a vein that targets specific cells in the immune system to help treat minimal change disease.

  • Prednisolone

    is a type of steroid medicine taken by mouth that helps reduce inflammation and manage the immune system response.

What is already known about the treatment

  • Rituximab

    This medication is administered through an intravenous infusion into the bloodstream. It is a well-established treatment used to manage various immune system disorders and certain types of cancer. As a monoclonal antibody, it works by specifically targeting and attaching to a protein on the surface of certain immune cells to help remove them from the body. It is classified as a biological therapy that modifies the immune response.

  • Tacrolimus

    This medicine is taken orally as a pill or liquid. It is widely used in medical practice to prevent the body from rejecting transplanted organs and to treat certain autoimmune conditions. At a molecular level, it works by blocking specific signals within immune cells that would otherwise trigger an inflammatory response. It is classified as an immunosuppressant drug.

  • Betamethasone sodium phosphate

    This substance is administered orally to help manage various inflammatory conditions. It is an established medication used to reduce swelling and suppress overactive immune responses. It works by entering cells and altering how certain genes function to decrease the production of chemicals that cause inflammation. It belongs to a class of drugs known as corticosteroids.

  • Obinutuzumab

    This medication is given via intravenous infusion directly into a vein. It is a newer biological agent currently being studied for its effectiveness in treating specific kidney diseases like minimal change disease. It works by binding to a specific marker on the surface of B-cells, which are a type of white blood cell, to trigger their destruction. It is classified as a targeted monoclonal antibody.

  • Prednisolone

    This medication is taken orally to treat many different inflammatory and allergic conditions. It is a long-standing treatment used to dampen the body's immune response during various health crises. It functions by mimicking natural hormones to reduce the activity of cells that cause inflammation throughout the body. It is categorized as a corticosteroid.

Investigated diseases

Minimal change disease - This is a condition that affects the filtering units of the kidneys. It occurs when the structure of the kidney's filtering cells changes, causing them to become leaky. This leakiness allows large amounts of protein to pass from the blood into the urine. The condition can progress through periods of high protein loss followed by periods of stability. It may also involve recurring episodes where the symptoms return after initial improvement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520641-69-00Protocol codeOBELIX-NEPHROSISEstimated enrolment48 patientsSponsorMedizinische Universitaet Innsbruck

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