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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Uasqsmtokv Mnjoqxg Cekwet Hvyonttezhsabjqsb	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	15.04.2026
France	Not yet recruiting	15.04.2026
Germany	Not yet recruiting	15.04.2026

Trial locations

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.

Investigated diseases:

Nephropathy

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 ID:

2025-520641-69-00

Protocol code:

OBELIX-NEPHROSIS

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?