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Study of Obinutuzumab for Patients with Primary Membranous Nephropathy Resistant or Intolerant to Rituximab

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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 kidney condition known as Primary Membranous Nephropathy. This condition can lead to a group of symptoms called nephrotic syndrome, which includes high levels of protein in the urine, low levels of protein in the blood, and swelling. The study is testing a medication called Obinutuzumab to see if it can help patients who have not responded well to another treatment called rituximab. Some patients may be resistant to rituximab, meaning it doesn't work for them, or they may be dependent on it, meaning they need it regularly to manage their symptoms. Others may be intolerant, meaning they cannot take rituximab due to severe side effects.

The purpose of the study is to evaluate if Obinutuzumab can help these patients achieve remission, which means reducing or eliminating the symptoms of nephrotic syndrome. The study will also assess if the medication is safe and well-tolerated. Participants will receive the treatment and be monitored over a period of time to see how their condition changes. The study will look at how many patients experience a complete or partial remission of their symptoms and will also track any side effects that occur during the treatment.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes measuring protein levels in the urine and blood, as well as other health indicators. The study aims to provide valuable information on the effectiveness and safety of Obinutuzumab for patients with Primary Membranous Nephropathy who have limited treatment options due to their response to rituximab.

The research process

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

Step 1
Initial visit and consent
Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written consent to participate in the study. This consent confirms your understanding and agreement to follow the study procedures.
Step 2
Screening and eligibility confirmation
During this phase, your medical history will be reviewed, and tests will be conducted to confirm your eligibility. This includes verifying your diagnosis of primary membranous nephropathy and ensuring you meet all the study criteria.
Step 3
Treatment initiation
If eligible, you will begin treatment with obinutuzumab. This medication is administered as a solution for infusion, which means it is given through a vein. The schedule and dosage will be explained to you by the study team.
Step 4
Monitoring and follow-up
Throughout the study, you will have regular follow-up visits. These visits are to monitor your health and the effects of the treatment. You may undergo various tests, including blood tests and urine tests, to assess your response to the medication.
Step 5
Completion of treatment
After completing the treatment phase, you will have a final evaluation. This will include a comprehensive assessment of your health and the outcomes of the treatment. The study team will discuss the results with you.
Step 6
Long-term follow-up
You may be asked to participate in long-term follow-up visits to monitor your health over time. These visits help gather information on the long-term effects and safety of the treatment.

Who can join the trial?

10 criteria

Must be an adult (18 years or older) on the day of signing the consent form.
Must agree to use effective contraception from 28 days before starting treatment until 18 months after stopping treatment. Men must agree not to donate semen during this time, and women must agree to take pregnancy tests during the study.
Must have a biopsy-proven diagnosis of primary membranous nephropathy. A biopsy is a medical test where a small piece of tissue is taken from the body to be examined.
Must have a recent (within the last six months) kidney biopsy to confirm the diagnosis and assess the severity of the condition.
Must be at high risk of kidney disease progression due to persistent high levels of protein in the urine, despite treatment with certain medications (ACE inhibitors or ARBs) at the highest tolerated doses for at least six months.
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Must have failed to respond to rituximab therapy due to one of the following:
- Rituximab-Intolerance: Severe allergic reactions to rituximab that prevent further use of the drug.
- Rituximab-Resistance: No improvement in nephrotic syndrome after rituximab treatment, with certain lab results showing no change.
- Rituximab-Dependence: Frequent relapses of nephrotic syndrome despite initial improvement after rituximab treatment.
- Must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m². This is a measure of kidney function.
- Must be able to understand and sign a written consent form to participate in the study.

Who cannot join the trial?

6 criteria

Patients who are allergic or have a bad reaction to Rituximab cannot participate. Rituximab is a medication used to treat certain immune system conditions.
Patients who do not respond to Rituximab or need it regularly to manage their condition cannot participate.
Patients who are not able to tolerate Obinutuzumab cannot participate. Obinutuzumab is a medication similar to Rituximab, used for treating certain immune system conditions.
Patients who are pregnant or breastfeeding cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
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Istituto Di Ricerche Farmacologiche Mario Negri
Ranica, Italy

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Investigated drugs

Obinutuzumab is a medication used in this clinical trial to help patients with a kidney condition called primary membranous nephropathy. This condition can cause a lot of protein to leak into the urine, leading to a problem known as nephrotic syndrome. In this study, Obinutuzumab is being tested to see if it can help patients who have not responded well to another treatment called Rituximab, or who cannot tolerate Rituximab. The goal is to see if Obinutuzumab can help reduce the symptoms of nephrotic syndrome and if it is safe for these patients to use.

What is already known about the treatment

Obinutuzumab – Obinutuzumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its potential use in treating primary membranous nephropathy, particularly in patients who do not respond to or cannot tolerate another medication called rituximab. The main therapeutic indication for obinutuzumab in this context is to help reduce symptoms of nephrotic syndrome, a kidney disorder. At the molecular level, obinutuzumab works by targeting and binding to a specific protein on the surface of certain immune cells, leading to their destruction. It is classified as a monoclonal antibody, a type of medication designed to target specific cells in the body.

Investigated diseases

Primary Membranous Nephropathy – Primary Membranous Nephropathy is a kidney disorder characterized by the thickening of the membranes within the glomeruli, which are tiny blood vessels in the kidneys. This thickening is due to the accumulation of immune deposits, leading to damage in the filtering units of the kidneys. As the disease progresses, it often results in nephrotic syndrome, which includes symptoms such as high levels of protein in the urine, low levels of protein in the blood, swelling, and high cholesterol. Over time, the kidney's ability to filter waste and excess fluid from the blood can become impaired. The condition is often associated with the presence of antibodies against a specific protein in the kidney, known as the phospholipase A2 receptor (PLA2R). The progression of the disease can vary, with some individuals experiencing spontaneous remission while others may have persistent symptoms.