RecruitingPHASE3INTERVENTIONAL

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)

This study is testing a new medicine, felzartamab, for adults who have a kidney condition called IgA nephropathy (IgAN). IgAN happens when a type of antibody, called IgA, builds up in the kidneys, causing damage and leading to protein leaking into the urine. Felzartamab aims to stop these harmful antibodies. The main goal is to find out if felzartamab can reduce the amount of protein in the urine. Researchers will also check how well the kidneys are working and if the medicine is safe. Participants will receive either felzartamab or a dummy medicine (placebo) through an IV drip, without knowing which they are getting, and will be followed for about two years.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Biogen

Enrolment target

454

Start

08 May 2025

Estimated completion

05 Jun 2029

Immunoglobulin A Nephropathy (IgAN)

What is this study about?

This research study is looking into a new medicine called felzartamab for people who have a kidney disease known as IgA nephropathy, or IgAN. Your kidneys are amazing filters that clean your blood. With IgAN, a specific type of protein, called IgA, builds up in these filters over time. This build-up causes swelling and damage, which can make your kidneys less able to do their job properly. One common sign of this damage is having too much protein in your urine, which doctors call proteinuria.

Felzartamab is designed to specifically target and reduce the immune cells that produce these abnormal IgA proteins. By doing this, the researchers hope to lessen the damage to the kidneys and improve kidney function for people with IgAN. The main thing they want to learn is whether felzartamab can reduce the amount of protein that leaks into your urine.

They will also be carefully monitoring how well your kidneys are filtering your blood, and they will keep a close eye on any side effects to make sure the treatment is safe. Understanding how your body processes the medicine is also part of this important research. This study is a "Phase 3" trial, which means it's one of the final steps before a new medicine might be approved for wider use.

Key takeaways

This study is testing a new medicine (felzartamab) for IgAN.
It aims to reduce protein in urine and improve kidney function.
Participants will receive infusions of either felzartamab or a placebo.
The study lasts about two years, with regular clinic visits.
Researchers will monitor safety and how the medicine works in the body.
You won't know if you're getting the actual drug or a dummy medicine.

Who may be eligible?

To join this study, you would need to have been diagnosed with IgAN by a kidney biopsy in the last 10 years (or within the last 2 years if you also have a certain type of diabetes). Your kidneys must still be working fairly well, with a specific measure called eGFR generally above 30. You also need to have protein in your urine, which is a key sign of IgAN damage, at a certain level.

You should already be taking stable doses of standard medications for IgAN, such as blood pressure medicines (like ACE inhibitors or ARBs), or other specific kidney protection drugs, for at least 3 months. These doses must remain the same throughout the entire study. If you're on a new type of medicine for IgAN, you can't be taking ACE inhibitors or ARBs at the same time.

There are also some reasons why you might not be able to join. For example, if your IgAN is caused by another health condition, or if you have a rapidly worsening type of IgAN that can't be explained by other factors. You also can't have other serious kidney diseases or certain specific types of IgAN. The research team will carefully check all these details to see if this study is right for you.

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.

Have you been diagnosed with IgAN by a kidney biopsy?
Are your kidneys still working reasonably well (specific eGFR levels apply)?
Do you have protein in your urine?
Have you been on stable doses of your regular IgAN medications for at least 3 months?
Do you have any other serious kidney diseases or specific types of IgAN?
Do you have IgAN caused by another separate medical condition?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a screening visit to check if you meet all the requirements. If you do, you'll be randomly assigned to receive either the study medicine, felzartamab, or a placebo (a dummy medicine that looks the same but contains no active drug). Neither you nor the study doctors will know which one you are receiving – this is called a 'blinded' study and helps make the results fair.

The medicine will be given through a drip into your arm (intravenous infusion). You'll receive these infusions for 24 weeks. After this treatment period, there will be a follow-up period of 80 weeks to continue monitoring your health. In total, you'll have 17 visits to the clinic over roughly two years. These visits will involve checks on your health, blood tests, and urine tests to see how the treatment is affecting you and your kidneys.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of joining this study is that you might receive regular, high-quality medical care and one of the study treatments, which could potentially slow down your kidney disease. However, there's no guarantee the treatment will help you. Potential risks include side effects from the study drug, discomfort from infusions, blood tests, or other procedures. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (239)

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

Applied Research Center of Arkansas
Verified postcode
Little Rock, United States· Recruiting
Kidney & Hypertension Center - Apple Valley
Verified postcode
Apple Valley, United States· Recruiting
Scripps Green Hospital
Verified postcode
Carlsbad, United States· Recruiting
National Institute of clinical Research Administration Office
Verified postcode
Garden Grove, United States· Withdrawn
UCLA Health David Geffen School of Medicine
Verified postcode
Los Angeles, United States· Recruiting
FOMAT Medical Research - FOMAT - PPDS
Verified postcode
Oxnard, United States· Recruiting
North America Research Institute-San Dimas
Verified postcode
San Dimas, United States· Recruiting
Nova Clinical Research, LLC
Verified postcode
Bradenton, United States· Recruiting
University of Florida - Gainesville - 1600 SW Archer Rd
Verified postcode
Gainesville, United States· Not yet recruiting
Royal Research, Corp.
Verified postcode
Hollywood, United States· Recruiting
Central Florida Kidney Specialists
Verified postcode
Orlando, United States· Recruiting
CDC Research Institute, LLC
Verified postcode
Port Saint Lucie, United States· Recruiting

Common questions

What is IgA nephropathy (IgAN)?

It's a kidney disease where a protein called IgA builds up in your kidneys, causing damage and affecting their ability to filter blood.

What is felzartamab?

It's a new medicine being tested that aims to target and reduce the immune cells that cause the harmful IgA deposits in your kidneys.

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

No, neither you nor the doctors will know. This helps ensure the results are accurate and fair.

How long will I be in the study?

The study will last for about two years, including a treatment period and a follow-up period.

What kind of tests will I have?

You'll have regular blood and urine tests, and your kidney function will be closely monitored.

How to find out more

US Biogen Clinical Trial Center

clinicaltrials@biogen.com 866-633-4636 Official trial record

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