Active not recruitingPHASE3INTERVENTIONAL

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

This study is investigating a new medication called sibeprenlimab for people with a kidney condition known as IgA nephropathy, or IgAN. This condition can cause kidney damage over time. The main goal is to find out if sibeprenlimab, given by injection every four weeks, can help reduce the amount of protein leaking into the urine after nine months of treatment. Researchers also want to see if it can slow down the decline in kidney function over roughly two years. About 450 people with IgAN and certain kidney function levels will take part, with a small group of people with more advanced IgAN also included. Participants will either receive the new medicine or a placebo (a dummy medicine) to compare their effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Enrolment target

530

Start

15 Mar 2022

Estimated completion

19 Jan 2027

Immunoglobulin A Nephropathy

What is this study about?

This study is looking into a new treatment called sibeprenlimab for a kidney condition known as IgA nephropathy (IgAN). In IgAN, a part of your immune system, called immunoglobulin A (IgA), builds up in your kidneys. Over time, this can cause damage, leading to protein leaking into your urine and your kidneys not working as well.

The main aim of this study is to see if sibeprenlimab can reduce the amount of protein in your urine after about nine months. High levels of protein in the urine can be a sign that your kidneys are under stress. Researchers also want to find out if this new medicine can help protect your kidney function and slow down any further decline over almost two years.

This is a important step in finding better ways to manage IgAN, potentially helping people keep their kidneys healthier for longer. Participants will be randomly given either the study medicine or a placebo (a treatment that looks the same but has no active medicine) so that the researchers can accurately compare their effects. This is a common and important way to test new medicines.

Key takeaways

This study is for people with IgA nephropathy (IgAN).
It tests a new medicine, sibeprenlimab, against a placebo.
The main goals are to reduce urine protein and protect kidney function.
Participation involves injections every 4 weeks and regular check-ups.
The study lasts about two years, with close monitoring for the first nine months.
You won't know if you're getting the active drug or the placebo.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of IgA nephropathy (IgAN) based on a kidney biopsy. Your kidney function, measured by something called eGFR, generally needs to be 30 ml/min or higher. You should also be taking stable doses of certain blood pressure medicines (like ACE inhibitors or ARBs) if your doctor has prescribed them, for at least three months.

There are also some things that would mean you can't join. For example, if your IgAN is caused by another condition, or if you have other types of chronic kidney disease besides IgAN. You also can't have certain other kidney conditions like lupus nephritis, or if your kidney biopsy shows too much scarring. Conditions like uncontrolled high blood pressure, certain infectious diseases, or poorly controlled diabetes would also stop you from taking part.

Your doctor will discuss all the detailed requirements with you to see if this study is a good fit. There's also a smaller group for people with slightly lower kidney function (eGFR between 20 and 29 ml/min), which has slightly different rules.

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 biopsy-confirmed diagnosis of IgA nephropathy (IgAN)?
Is your kidney function (eGFR) generally 30 ml/min or higher?
Are you taking stable doses of any prescribed blood pressure medicines (ACE inhibitors/ARBs)?
Do you have any other serious kidney diseases apart from IgAN?
Do you have uncontrolled high blood pressure or poorly controlled diabetes?

Answer every question to see your result.

What does participation involve?

If you join this study, you might receive either the study medicine (sibeprenlimab) or a placebo, given as an injection under your skin every four weeks. You won't know which one you're getting, nor will your study doctor, to ensure the results are unbiased. You'll have regular visits to the clinic for check-ups, blood and urine tests, and to measure your kidney function. The main part of the study will last for about nine months, where they'll closely monitor the protein in your urine. After that, they will continue to track your kidney health for a total of around 24 months to see how your kidney function changes over time. Your participation will involve regular appointments and tests over this entire period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that the new medicine, sibeprenlimab, might improve your kidney condition by reducing protein in your urine or slowing down kidney damage. However, there's also a chance you might receive the placebo and not get the active treatment. Potential risks could include side effects from the study medicine, which will be carefully monitored by the study team. You'll receive a full explanation of all known potential risks before deciding to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (308)

University of Alabama at Birmingham - Site #336
Verified postcode
Birmingham, United States
Mayo Clinic Arizona - Site #363
Verified postcode
Phoenix, United States
University of Arkansas for Medical Sciences - Site #353
Verified postcode
Little Rock, United States
Amicis Research Center - Site #341
Verified postcode
Granada Hills, United States
University of CA San Diego - Site #351
Verified postcode
La Jolla, United States
California Institute of Renal Research - Site #371
Verified postcode
La Mesa, United States
Loma Linda University Health Care Clinical Trial Center Clinic - Site #372
Verified postcode
Loma Linda, United States
Academic Medical Research Institute - Site #333
Verified postcode
Los Angeles, United States
Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325
Verified postcode
Los Angeles, United States
Stanford University - Site #370
Verified postcode
Palo Alto, United States
North America Research Institute - Site #335
Verified postcode
San Dimas, United States
University of California, San Francisco - Site #377
Verified postcode
San Francisco, United States

Common questions

What is IgA nephropathy (IgAN)?

IgAN is a chronic kidney disease where a specific antibody (IgA) builds up in the kidneys, causing damage and affecting their ability to filter waste from your blood.

What is sibeprenlimab?

Sibeprenlimab is the new medicine being tested in this study. It's designed to potentially help reduce the effects of IgAN on your kidneys.

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine to see if the new treatment actually works.

How will the medicine be given?

If you receive the study medicine, it will be given as an injection under your skin every four weeks.

How long will the study last?

The main part of the study will last about nine months, but your kidney function will be monitored for a total of around two years.