Not recruitingRare disease

Study of Felzartamab for Patients with Membranous Nephropathy Resistant to Anti-CD20 Therapy

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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 called membranous nephropathy, which affects the kidneys and can lead to a condition known as nephrotic syndrome. Nephrotic syndrome is characterized by high levels of protein in the urine, which can cause swelling and other health issues. The study is testing a treatment called Felzartamab, also known by its code name MOR202. Felzartamab is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body. The purpose of the study is to see if Felzartamab can help reduce the amount of protein in the urine of patients who have not responded well to previous treatments.

Participants in the study will receive Felzartamab through an infusion, which means the medication is given directly into the bloodstream. The study will last for up to 24 months, during which time participants will have regular check-ups to monitor their health and the effects of the treatment. The study will also involve the use of other medications, such as Aminohippuric Acid and Omnipaque, which are used for diagnostic purposes to help doctors better understand how the kidneys are functioning.

The main goal of the study is to determine if Felzartamab can effectively reduce the protein levels in the urine of patients with membranous nephropathy. Researchers will also look at other health indicators, such as kidney function and overall quality of life, to assess the impact of the treatment. The study will help provide valuable information about the potential benefits and risks of using Felzartamab for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.
A biopsy is required to confirm the diagnosis of membranous nephropathy. Blood pressure and kidney function are also evaluated.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. These include 24-hour urine collection to measure protein levels and blood tests to assess kidney function and antibody levels.
Step 3
Treatment initiation
The treatment involves the administration of Felzartamab (MOR202), a human anti-CD38 antibody, as a solution for infusion.
The dosage and frequency of administration are determined by the study protocol and are monitored by the medical team.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted at 6, 9, 12, 18, and 24 months to monitor the effects of the treatment.
These assessments include urine and blood tests to measure protein levels, kidney function, and antibody levels, as well as evaluations of overall health and quality of life.
Step 5
End of study evaluation
At the end of the study, a comprehensive evaluation is conducted to assess the overall effectiveness of the treatment.
The primary goal is to determine the reduction in urinary protein excretion and the achievement of complete or partial remission of nephrotic syndrome.

Who can join the trial?

10 criteria

Must be at least 18 years old.
Must have a confirmed diagnosis of membranous nephropathy through a kidney biopsy. This can be with or without certain antibodies in the blood called anti-PLA2R or anti-THSD7A.
Must be on treatment with medications that block the renin-angiotensin system (RAS), such as ACE inhibitors or ARBs, at the highest dose you can handle. Your blood pressure should be well-controlled, with readings below 140/90 mmHg in at least three checks during the screening.
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Must meet one of the following conditions:
- Anti-CD20 Resistance: Still have high levels of protein in the urine (3.5 grams or more per day) even after treatment with anti-CD20 antibodies, with less than a 50% reduction in protein levels compared to before treatment, at least 12 months after the therapy.
- Anti-CD20 Dependence: Have frequent relapses of nephrotic-range proteinuria (high levels of protein in the urine) for more than half of the time in the last five years or since the disease started, despite repeated treatments with anti-CD20 antibodies.
- Must have an estimated glomerular filtration rate (GFR) greater than 30 ml/min/1.73m², which is a measure of kidney function, and less than 50% of the kidney's filtering units (glomeruli) should be scarred if a kidney biopsy is done.
- Must have stopped anti-CD20 therapy, such as rituximab or other similar treatments, for at least 12 months.
- Must not have used any immunosuppressive therapy, like steroids or other specific drugs, in the last 6 months. If these therapies were used for less than 2 weeks, no waiting period is needed before joining the study.
- Must have completed the COVID-19 vaccination.
- Must provide written informed consent, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

10 criteria

Patients who have other serious kidney diseases besides membranous nephropathy. Membranous nephropathy is a condition where the kidney's filtering units are damaged.
Patients who have had a kidney transplant.
Patients who are currently receiving treatment with other experimental drugs.
Patients who have a history of severe allergic reactions to similar treatments.
Patients who are pregnant or breastfeeding.
Patients who have uncontrolled high blood pressure.
Patients who have active infections that require treatment.
Patients who have a history of cancer within the last five years, except for certain skin cancers.
Patients who have a history of drug or alcohol abuse within the last year.
Patients who have any other medical condition that the study doctors believe would make it unsafe for them to 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

MOR202 (felzartamab) is a human antibody that targets a protein called CD38. It is being studied as a rescue therapy for patients with membranous nephropathy, a kidney condition. This medication is used in patients who have not responded well to previous treatments targeting another protein, CD20. The goal of using MOR202 is to reduce or stop the excessive loss of protein in the urine, which is a common problem in this kidney disease.

What is already known about the treatment

Felzartamab – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating membranous nephropathy, particularly in patients who have not responded to other treatments targeting CD20 proteins. Felzartamab works by targeting and binding to the CD38 protein on certain immune cells, which helps reduce inflammation and damage in the kidneys. It is classified as a monoclonal antibody, a type of drug designed to specifically target and neutralize certain proteins in the body.

Investigated diseases

Membranous nephropathy – 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 increased protein leakage into the urine, a condition known as proteinuria. Over time, this can result in nephrotic syndrome, which includes symptoms such as swelling, high cholesterol, and low levels of protein in the blood. The disease can progress slowly, and in some cases, it may lead to chronic kidney disease. The exact cause of membranous nephropathy is often unknown, but it can be associated with other conditions or medications. It is considered a rare disease and can vary significantly in its progression and severity among individuals.