AuthorisedTherapeutic confirmatory (Phase III)Interventional

A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy

This research is an important long-term study for adults living with IgA nephropathy, a kidney disease. The main goal is to carefully check the safety of a new medication called zigakibart and how well people tolerate it over an extended period. Researchers will be looking out for any side effects, how serious they are, and if they are linked to the medicine. The study will also measure how zigakibart affects kidney function over 96 weeks (about two years), including changes in protein in the urine and overall kidney performance. This information will help doctors understand if zigakibart could be a safe and effective long-term treatment option.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novartis Pharma AG

Enrolment target

Start

04 May 2026

IgA nephropathy

What is this study about?

This study is called an 'open-label extension' study, which means it follows on from a previous study. If you participated in an earlier trial and it's suitable, you might be invited to join this longer-term study. The main purpose is to gather more information about a new medicine called zigakibart for people with a kidney condition called IgA nephropathy. In IgA nephropathy, your immune system mistakenly attacks your kidneys, which can lead to kidney damage and kidney disease.

Researchers are particularly interested in the long-term safety of zigakibart. They want to know what kinds of side effects might occur, how often they happen, and how severe they are. They will also look closely at any specific side effects that might be expected with this type of medicine. This information is really important because it helps scientists and doctors understand if zigakibart is a safe treatment option to use over many months or even years.

Beyond safety, the study will also look at how zigakibart affects your kidney health over time. They will measure things like how much protein is in your urine, which is a sign of kidney damage, and how well your kidneys are filtering waste from your blood. By carefully tracking these measures, researchers hope to learn if zigakibart can help protect your kidneys and slow down the progression of IgA nephropathy. The study will last for 96 weeks, which is about two years.

Key takeaways

This study is testing the long-term safety of a medicine called zigakibart for IgA nephropathy.
It will also check how zigakibart affects kidney function over two years.
Only adults who have already participated in a previous study with zigakibart are eligible.
Regular clinic visits, blood tests, and urine tests will be part of taking part.
Your health and safety will be closely monitored by the study team.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you must be an adult, at least 18 years old, and have been diagnosed with IgA nephropathy. This study is an 'extension' of a previous trial, which means it's for people who have already taken part in an earlier study involving the medication zigakibart.

Because it's a follow-up, you would typically be invited to join if you met specific health criteria during the first study and are still considered a good fit. This helps ensure that the researchers can continue to safely monitor the long-term effects of the medicine.

Generally, if you're an adult with IgA nephropathy who has participated in a related study and received zigakibart, you might be eligible. The hospital staff running the study will check if you meet all the detailed requirements.

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 IgA nephropathy?
Have you already taken part in a previous clinical study involving zigakibart?
Are you willing and able to attend regular clinic appointments for about two years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would continue to receive the study medicine, zigakibart. You would have regular visits to the clinic over a period of 96 weeks (about two years). These visits are important for the research team to monitor your health and the effects of the medicine.

During your visits, you can expect to have various checks. These will likely include blood tests and urine tests to see how your kidneys are working, measure the levels of the study medicine in your body, and check for any immune reactions. You'll also have your vital signs (like blood pressure and heart rate) checked regularly. The research team will ask you about any side effects or changes in your health you might be experiencing. All these assessments help the doctors understand the long-term safety and effects of zigakibart.

Potential risks and benefits

Taking part in a clinical study means you might receive a new medicine that could potentially help manage your IgA nephropathy. However, as with any new medicine, there's always a possibility of unknown side effects or that it may not work for everyone. The study team will closely monitor your health for any side effects, which they will thoroughly explain to you. Remember, joining a study is always your choice, and you have the right to withdraw at any time without giving a reason, and this will not affect your medical care.

Locations (8)

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

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Unverified
Belgium
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Unverified
France
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Unverified
Czechia
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Unverified
Croatia
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Unverified
Greece
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Unverified
Germany
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Unverified
Italy
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Unverified
Spain

Common questions

What is IgA nephropathy?

IgA nephropathy is a condition where a type of protein, called immunoglobulin A (IgA), builds up in your kidneys. This can cause inflammation and damage, affecting how well your kidneys work.

What does 'open-label' mean?

Open-label means that both you and the study doctors will know that you are receiving the study medicine, zigakibart. In some studies, people don't know if they're getting the medicine or a dummy treatment.

How long will this study last?

This study is planned to last for 96 weeks, which is about two years, to look at the long-term effects of the medicine.

Will I have to pay to be in the study?

No, you will not have to pay for the study medicine or the special assessments required as part of the trial. Sometimes, travel expenses may be covered; discuss this with the study team.

What happens if I feel unwell during the study?

The study team will give you clear instructions on what to do if you feel unwell or have any concerns during the study. They are there to support you and ensure your safety.