Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Rescue Therapy with the Human Anti-CD38 Antibody MOR202 (felzartamab) in Patients with Membranous Nephropathy who Failed Anti-CD20 Target Therapy (MONET study)

The MONET study is testing a new treatment called felzartamab for a kidney disease called membranous nephropathy. This condition causes the kidneys to leak important proteins into the urine. The study is specifically for patients who have already tried a different type of treatment (anti-CD20 therapy) but haven't seen enough improvement. The main goals are to see if felzartamab can reduce the amount of protein leaking into the urine over 12 months, and if it can help patients achieve either a complete or partial recovery from the disease. Researchers will also be looking at how safe the medicine is and how it affects patients' overall well-being. It's a Phase II study, meaning it's still in the earlier stages of drug development.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Istituto Di Ricerche Farmacologiche Mario Negri

Enrolment target

Start

24 Jun 2024

Membranous nephropathy

What is this study about?

This study, called MONET, is trying out a new medicine, felzartamab, for a kidney problem known as membranous nephropathy. In this condition, the tiny filters in your kidneys get damaged, causing them to leak important proteins into your urine. This can lead to swelling, tiredness, and other health issues.

This new treatment is being explored especially for people who have already tried a common treatment (called anti-CD20 therapy) but didn't get better. The researchers want to know if felzartamab can specifically help reduce the amount of protein that's being lost in the urine. This is a really important step because too much protein loss can be harmful to your kidneys over time.

The main things the study aims to find out are whether the medicine helps reduce protein in the urine after 12 months, and if it can lead to either a full or partial recovery from the kidney disease. They will also be closely watching for any side effects and how the medicine affects a person's overall quality of life. Understanding these things helps doctors find better ways to treat membranous nephropathy.

Key takeaways

This study is for adults with a kidney disease called membranous nephropathy.
It's exploring a new medicine, felzartamab, for those who haven't responded well to previous treatments.
The main goals are to reduce protein in urine and help kidneys recover.
Participants will receive infusions and have regular health checks for 24 months.
The study will also look at safety and how the medicine affects quality of life.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study welcomes both men and women.

A key requirement is that you must have a kidney condition called membranous nephropathy. Also, it's important that previous treatments for this condition, specifically those that target something called CD20, haven't worked well enough for you.

There will be other detailed medical checks to make sure the study is a good fit for your health and that it's safe for you to take part. Your doctor can help determine if you meet all the necessary criteria.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with membranous nephropathy?
Have you previously tried and not fully responded to anti-CD20 treatments for your kidney condition?
Are you able to attend regular clinic appointments for two years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, felzartamab, through an infusion (like a drip) over some time. You would have regular visits to the clinic or hospital, where medical staff would check your health, take blood and urine samples, and monitor how your kidneys are doing.

These visits would happen at specific times over 24 months, including checks at 6, 9, 12, 18, and 24 months. During these visits, doctors would measure the amount of protein in your urine, check other kidney indicators, and ask you about your general well-being and any side effects you might be experiencing. You would also complete questionnaires about your quality of life. The total commitment for the study would be for two years.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving your kidney condition, especially if previous treatments haven't worked for you. However, as with any new medicine, there's a chance of side effects, which the medical team would explain fully. You would receive close medical attention throughout the study, which could be beneficial. It's important to remember that joining a clinical study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is membranous nephropathy?

It's a kidney disease where the filters in your kidneys get damaged, causing them to leak protein into your urine.

What is felzartamab?

It's a new medicine being tested in this study, designed to help treat membranous nephropathy.

Why is this study important?

It aims to find a new treatment option for people whose kidney disease hasn't improved with other standard medicines.

How long does the study last?

If you join, your participation would last for 24 months (two years).

Will I know if the medicine is working for me?

The study team will regularly check your urine protein levels and other health markers to see how you are responding.