Active not recruitingPHASE3INTERVENTIONAL

A Study of Zigakibart in Adults With IgA Nephropathy

This study is looking into a new medicine called BION-1301 for adults who have a kidney condition called IgA Nephropathy. Doctors want to find out how safe and effective this medicine is. Around 330 people will take part, some receiving the new medicine, some another active drug, and others a dummy treatment (placebo). This will help researchers understand if BION-1301 can improve kidney function over two years. There's also a smaller group to explore the medicine's effects in people with more advanced kidney issues. After the main study, participants might be able to continue receiving the medicine.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

383

Start

06 Jul 2023

Estimated completion

25 Jan 2028

IgA Nephropathy Immunoglobulin A Nephropathy

What is this study about?

This study is focusing on a new medicine called BION-1301 for a kidney disease known as IgA Nephropathy. People with IgA Nephropathy have a problem where their immune system makes a type of antibody, called IgA, that builds up in the kidneys. Over time, this build-up can damage the kidneys and prevent them from working properly, sometimes leading to serious kidney problems.

The main goal of this study is to see if BION-1301 can help improve kidney function in adults with IgA Nephropathy. To do this, some people will receive BION-1301, others will receive a different study drug, and some will be given a placebo, which looks like the study medicine but contains no active drug. This comparison helps doctors understand if any changes are truly due to the new medicine.

Researchers will carefully monitor participants' kidney function throughout the study to see how the different treatments affect them. By taking part, you could contribute to finding new and better ways to manage IgA Nephropathy, potentially helping future patients.

Key takeaways

Tests a new medicine, BION-1301, for IgA Nephropathy.
Compares BION-1301 to another drug and a dummy medicine (placebo).
Study lasts for about two years with optional extension.
Aims to improve kidney function in adults with IgA Nephropathy.
Participants will receive regular medical check-ups.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) with a confirmed diagnosis of IgA Nephropathy. This diagnosis must have been made within the last 10 years, and doctors will check that it's not due to other health problems like certain infections or autoimmune diseases.

Your kidneys need to be working at a certain level. Specifically, a test called eGFR (which measures kidney function) should be 30 mL/min or higher. You also need to have a certain amount of protein in your urine, which will be measured by a laboratory.

You should already be on stable doses of certain blood pressure medicines like ACE inhibitors or ARBs, if they are suitable for you, for at least 3 months. You might also be taking other kidney-protecting medicines as long as they have been stable for the same period. There are some health conditions or medicines that would prevent you from joining, such as having certain other kidney problems or taking strong immune-suppressing drugs, or if your IgG levels are too low.

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?
Do you have a diagnosis of IgA Nephropathy confirmed by a kidney biopsy within the last 10 years?
Is your kidney function (eGFR) 30 mL/min or higher?
Do you have a certain amount of protein in your urine?
Are you on stable doses of certain blood pressure medicines if prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of three groups: one group will receive the new medicine BION-1301, another group will receive a different study medicine (Novartis FUB523), and the third group will receive a placebo (a dummy medicine). You won't know which group you're in, and neither will your doctor, to make sure the results are as fair as possible. The medicines will be given every two weeks for about two years (104 weeks).

Throughout the study, you'll have regular check-ups at the study site so doctors can monitor your health and how your kidneys are doing. Some of these check-ups might be possible from home if you can give yourself the study medicine. After the two-year treatment period, you might have the option to continue receiving BION-1301 in a separate, open-label study, where everyone knows they are receiving the active medicine. If you don't join that extension study, you'll have a final 24-week follow-up period to monitor your health.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving close medical attention and access to a new treatment that isn't yet widely available. However, there's no guarantee the new medicine will help you, or that it will be better than existing treatments or the placebo. Like all medicines, BION-1301 might have side effects, which the study will carefully monitor. You will be told about all known potential risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (200)

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

University of Alabama at Birmingham: The Kirklin Clinic
Verified postcode
Birmingham, United States
Nephrology Consultants, LLC
Verified postcode
Huntsville, United States
University of California, San Francisco
Verified postcode
San Francisco, United States
Valiance Clinical Research
Verified postcode
South Gate, United States
University of Colorado Hospital
Verified postcode
Aurora, United States
Denver Nephrology Research Division
Verified postcode
Denver, United States
Vida Medical Centers - Pembroke Pines
Verified postcode
Pembroke Pines, United States
NorthShore University HealthSystem
Verified postcode
Evanston, United States
Nephrology Associales of Northern Illinois and Indiana
Verified postcode
Hinsdale, United States
Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
Verified postcode
Fort Wayne, United States
University Of Iowa Hospitals And Clinics
Verified postcode
Iowa City, United States
Intermed Consultants
Verified postcode
Edina, United States

Common questions

What is IgA Nephropathy?

IgA Nephropathy is a kidney disease where a type of antibody, called IgA, builds up in the filters of your kidneys, causing damage and potentially leading to kidney problems.

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but contains no active drug. It helps researchers compare if the new medicine is truly effective.

How long will the study last?

The main treatment part of the study lasts for about two years (104 weeks). After that, you may have the option to continue receiving the medicine or will have a follow-up period.

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

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving the study medicine or the placebo. This helps ensure fair and accurate results.

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can choose to leave the study at any point, and it won't affect your regular medical care.