RecruitingPHASE3INTERVENTIONAL

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

This study is testing a new medicine, mezagitamab, for adults who have a kidney condition called IgA nephropathy. This condition happens when proteins build up in the kidneys and can cause damage over time. The main goal is to see if mezagitamab can help reduce protein in the urine, which is a sign of kidney damage, compared to a placebo (a dummy medicine). Researchers also want to check how safe mezagitamab is and how well people tolerate it. Some participants will be chosen by chance to receive either mezagitamab or the dummy medicine, while a smaller group will definitely receive mezagitamab. Taking part will involve regular visits to a clinic over about a year and a half.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Takeda

Enrolment target

347

Start

15 Jul 2025

Estimated completion

14 Jan 2030

Kidney Disease

What is this study about?

This study is about a kidney condition called IgA nephropathy, or IgAN for short. With IgAN, your body's immune system makes certain proteins that can build up in your kidneys. This build-up causes swelling and can harm your kidneys over time, making it harder for them to work properly. The new medicine being tested, mezagitamab, aims to help with this build-up and protect your kidneys.

The main thing the doctors want to find out is if mezagitamab can lower the amount of protein in your urine. High levels of protein in the urine are a common sign of IgAN and can show that your kidneys are struggling. They will compare mezagitamab to a 'placebo,' which looks just like the medicine but doesn't contain any active ingredients. This helps them see if any improvements are truly due to the new medicine. They will also keep a close eye on how safe the medicine is and if people have any side effects.

Another important part of the study is to see if mezagitamab can help keep your kidneys working well in the long run. By understanding how the medicine affects protein levels and kidney health, doctors hope to find a better way to treat IgAN and help people's kidneys stay healthier for longer.

Key takeaways

Tests a new medicine (mezagitamab) for IgA nephropathy.
Compares it to a dummy medicine (placebo) for effectiveness.
Focuses on reducing protein in urine and protecting kidneys.
Participation involves regular clinic visits for about 18 months.
You might receive the new medicine or a placebo by chance.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have been diagnosed with IgA nephropathy. Your diagnosis needs to be confirmed by a kidney biopsy, which is a small sample of your kidney tissue, taken within the last 10 years. If you haven't had one recently, you might need to have one for the study.

Your kidneys also need to be working to a certain level to be included. Doctors will check this with a blood test. Importantly, if you've already had a specific type of treatment for your immune system called anti-CD38 therapy, you generally can't join, unless you are in a special group for people who were in a previous study. You also need to be taking specific blood pressure or kidney-protecting medicines steadily for at least 12 weeks before starting the study.

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 by a kidney biopsy within the last 10 years?
Are your kidneys currently working at a certain level (your doctor can check this)?
Are you currently taking specific blood pressure or kidney-protecting medicines steadily?
Have you *not* had certain immune system treatments called anti-CD38 therapy (unless previously in TAK-079-1006 study)?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be placed into one of two main groups. Most people will be in the 'main group,' where you'll have a two out of three chance of receiving mezagitamab, and a one out of three chance of getting the placebo (dummy medicine). You won't know which one you're receiving. You'll take this treatment for about half a year, and then there will be about another half year of observation without treatment. This cycle will repeat once more, making the total study length a little over a year and a half. During this time, you'll have check-ups about once a month.

A smaller group of people will be in an 'open-label group.' This means they will definitely receive mezagitamab, and everyone will know it. This group includes people with particular kidney conditions or those who have taken mezagitamab in a previous study. All participants will need to visit the study clinic several times throughout the study for check-ups, tests, and to receive their medication.

Potential risks and benefits

Taking part in this study could potentially help advance our understanding of IgA nephropathy and how to treat it. If you receive mezagitamab, it might help improve your kidney condition by reducing protein in your urine and potentially protecting your kidney function. However, as with all new medicines, there's a chance of side effects or that the medicine may not work for you. The treatment you receive might also be a placebo, which means you wouldn't get any active medicine from the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (166)

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

UAB Nephrology Research Clinic at Paula Building
Verified postcode
Birmingham, United States· Recruiting
DCR Montgomery
Verified postcode
Montgomery, United States· Recruiting
Panoramic Health - Southwest Kidney Institute, PLC
Verified postcode
Surprise, United States· Recruiting
Panoramic Health - West Coast Kidney Institute (Fremont)
Verified postcode
Fremont, United States· Recruiting
Academic Medical Research Institute
Verified postcode
Los Angeles, United States· Recruiting
University of California Irvine
Verified postcode
Orange, United States· Recruiting
Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville)
Verified postcode
Jacksonville, United States· Recruiting
South Florida Research Institute
Verified postcode
Lauderdale Lakes, United States· Recruiting
Panoramic Health - Florida Kidney Physicians, LLC (Melbourne)
Verified postcode
Melbourne, United States· Recruiting
Bioresearch Partners
Verified postcode
Miami, United States· Recruiting
CTR Oakwater, LLC
Verified postcode
Orlando, United States· Recruiting
Bioresearch Partners
Verified postcode
Pembroke Pines, United States· Recruiting

Common questions

What is IgA nephropathy?

It's a kidney condition where certain proteins build up in your kidneys, causing swelling and damage over time.

What is a placebo?

A placebo looks like the study medicine but has no active ingredients. It helps researchers see if the real medicine is effective.

Will I know if I'm getting the real medicine or the placebo?

In the main group, you won't know initially. In the open-label group, everyone receives the real medicine and knows it.

How long will I be in the study?

The study lasts for about a year and a half, with regular check-ups throughout this time.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.