Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Study of immunological activity after personalized immunomodulatory therapy regulating the Th17 pathway in patients with extramembranous glomerulonephritis

This study is about a kidney condition called extramembranous glomerulonephritis, where the body's immune system mistakenly attacks the kidneys. We are testing a medicine named Pegasys® (interferon alpha) in adults with this condition. The main goal is to see if Pegasys® can lower the level of certain antibodies (called anti-PLA2R1) that cause kidney damage. We will also check if this treatment helps to reduce protein in the urine, a common sign of kidney problems, and if it affects other immune system markers. It's a Phase II study, meaning we are exploring if the treatment works and is safe, not comparing it to standard treatments yet. We also want to find the best way to give the medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

Start

08 Jun 2023

Extramembranous glomerulonephritis

What is this study about?

This study is looking at a condition called extramembranous glomerulonephritis, which is a rare but serious kidney disease. In this condition, the body's immune system, which normally fights off infections, starts to attack the kidneys by mistake. This can lead to kidney damage and problems like too much protein leaking into the urine, which is called proteinuria.

The researchers want to see if a medicine called Pegasys® (which is a type of interferon alpha) can help. This medicine is already used for some other conditions, but we're exploring if it can help calm down the immune system in people with extramembranous glomerulonephritis and stop it from attacking the kidneys. Specifically, they are interested in whether Pegasys® can reduce the levels of certain 'autoantibodies' – these are special proteins made by the immune system that cause the damage.

This is a Phase II study, which means it's an early-stage trial. The main aim is to understand if the treatment works by checking if those harmful antibodies go down after 6 months of Pegasys® treatment. We'll also be looking at other important things, like whether kidney function (measured by protein in the urine) improves, how the treatment affects other immune system markers, and if it's safe to use. We also want to figure out the best dose and schedule for giving the medicine.

Key takeaways

This study is testing a new approach for kidney disease (extramembranous glomerulonephritis).
It uses a medicine called Pegasys® to reduce harmful antibodies.
The study aims to improve kidney health and understand immune system changes.
It's an early-stage study (Phase II) for adults.
Participation involves injections and regular health checks for six months.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old, as the study is open to both men and women of any age above 18.

You would need to have been diagnosed with extramembranous glomerulonephritis. There will be other specific medical criteria that your doctor will check to make sure the study is right for you, and that it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with extramembranous glomerulonephritis?
Are you able to attend regular clinic visits and take medication?
Are you willing to have blood tests and other assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, Pegasys®, which is given as an injection, likely once or twice a month for six months. During this time, you would have regular visits to the clinic for medical check-ups. These visits would include blood tests to measure the levels of specific antibodies and other immune markers, as well as tests to check your kidney function and general health.

You would also be monitored for any side effects or changes in your health throughout the study period. Your existing stable medical treatments would continue alongside the study medicine. The total duration of active treatment and follow-up for the main part of the study would be approximately six months, with further follow-up visits to ensure your safety and monitor long-term effects.

Potential risks and benefits

Taking part in this study could potentially offer benefits by providing a new treatment option for extramembranous glomerulonephritis if Pegasys® proves to be effective. It might help to reduce the harmful antibodies damaging your kidneys and improve your kidney health. However, as with any medicine, there are potential risks and side effects associated with Pegasys®. These will be fully explained by the study team before you decide to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is extramembranous glomerulonephritis?

It's a kidney disease where your immune system attacks your kidneys, causing damage and often leading to protein leaking into your urine.

What is Pegasys®?

Pegasys® is a medicine that affects your immune system. It's being tested to see if it can calm down the immune response that causes kidney damage in this condition.

Will I stop my current medication if I join the study?

No, you would continue your usual stable treatments for your condition alongside the study medicine. This study is testing an add-on treatment.

How long will the treatment last?

The main treatment period with Pegasys® will last for six months. There will be regular check-ups during and after this period.

Is this a new medicine?

Pegasys® is an existing medicine, but its use for extramembranous glomerulonephritis is new and is being explored in this study.