RecruitingPHASE2INTERVENTIONAL

BAY3401016; Biomarker Study Alport

This study is investigating a new medication called BAY 3401016 for people aged 18 to 45 who have Alport Syndrome. Alport Syndrome is a genetic condition that mainly affects the kidneys, potentially leading to kidney failure. This new medicine is designed to block a protein called Semaphorin 3A (Sema3A), which scientists believe plays a role in causing kidney damage in Alport Syndrome. By blocking this protein, the researchers hope BAY 3401016 might help reduce the amount of protein leaking into the urine (a sign of kidney trouble) and slow down the worsening of kidney function. The main goal is to understand how well this treatment works in slowing down kidney damage in adults with a faster-progressing form of Alport Syndrome.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Bayer

Enrolment target

Start

19 Nov 2025

Estimated completion

27 Jul 2028

Alport Syndrome

What is this study about?

Alport Syndrome is a health condition passed down through families that mainly affects the kidneys, but can also cause problems with hearing and eyes. It happens because of changes in certain genes that are important for making a protein called collagen. Collagen is a building block that helps the kidneys work properly.

When someone has Alport Syndrome, their kidneys can gradually lose their ability to filter waste from the blood. This can lead to a condition called chronic kidney disease (CKD) and, over time, might result in kidney failure. A common sign that the kidneys aren't working as well as they should is when too much protein leaks into the urine – this is called proteinuria. Healthy kidneys don't usually let much protein pass through.

This study is testing a new medicine called BAY 3401016. It's a special type of drug designed to block a protein known as Semaphorin 3A (Sema3A). Researchers believe Sema3A might be involved in causing the kidney damage seen in Alport Syndrome. By blocking Sema3A, BAY 3401016 might help to reduce protein in the urine and slow down the rate at which kidney function gets worse. This study aims to find out if this new treatment can indeed help adults with Alport Syndrome keep their kidneys working better for longer.

Key takeaways

Tests a new medicine for Alport Syndrome.
Aims to slow down kidney damage.
For adults aged 18-45 with Alport Syndrome.
Will compare the new medicine to a placebo (dummy pill).
Close medical monitoring if you participate.

Who may be eligible?

This study is looking for adults between 18 and 45 years old who have Alport Syndrome. This includes men with X-linked Alport Syndrome or men and women with autosomal recessive Alport Syndrome.

To join, your kidneys should still be working reasonably well, but you should also have a certain amount of protein in your urine, which is a sign of kidney problems in Alport Syndrome. Your blood pressure also needs to be within a healthy range.

However, you won't be able to join if you have other types of kidney disease, if you have a serious illness that could affect your safety or the study results, or if you have had cancer. People with severe allergies, certain skin conditions (like eczema or severe acne), or allergies needing specific treatments (like steroids for asthma) are also not suitable for this study.

Quick self-check

Are you between 18 and 45 years old?
Have you been diagnosed with Alport Syndrome (X-linked male or autosomal recessive male or female)?
Is your kidney function above a certain level (eGFR at least 45 mL/min/1.73m2)?
Do you have a certain amount of protein in your urine (UACR at least 500mg/g)?
Is your blood pressure generally well-controlled (below 140/90 mmHg)?
Do you have any other significant medical conditions or a history of cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you would receive either the study medication, BAY 3401016, or a placebo (an inactive substance that looks like the real medicine). You wouldn't know which one you are getting. You would have regular visits to the clinic for health checks, blood tests, urine tests, and to monitor your kidney function and overall health. These visits would help the doctors see how your body is reacting to the treatment and if there are any changes. The total length of your participation in the study, including all follow-up, would be discussed with you by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment that might help slow the progression of your Alport Syndrome, and you would be closely monitored by medical professionals. However, there are also potential risks, including side effects from the study medication, which may or may not be known yet. As with any medical study, there's a chance the treatment might not work for you, or you might receive the placebo. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (60)

Nephrology Clinic at The Kirklin Clinic of UAB Hospital
Birmingham, United States· Not yet recruiting
The Peggy and Harold Katz Family Drug Discovery Center - Nephrology
Miami, United States· Not yet recruiting
Center for Advanced Pediatrics - Nephrology
Atlanta, United States· Not yet recruiting
Cardio Renal Institute
Chubbuck, United States· Recruiting
Tufts Medical Center | Nephrology Department
Boston, United States· Not yet recruiting
Renal Disease Research Institute | Landry
Dallas, United States· Recruiting
Hospital Británico
Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, Argentina· Recruiting
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.
Santa Fe, Argentina· Recruiting
St. Joseph's Healthcare - Hamilton
Hamilton, Canada· Recruiting
London Health Sciences Centre (LHSC) - University Hospital
London, Canada· Not yet recruiting

+48 more sites — see the official record for the full list.

Common questions

What is Alport Syndrome?

Alport Syndrome is a genetic condition that mainly causes kidney disease, but can also affect hearing and eyesight.

What is the new medicine BAY 3401016 supposed to do?

It aims to block a protein called Sema3A, which is thought to contribute to kidney damage in Alport Syndrome, hopefully slowing down the disease.

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

No, you won't know whether you are receiving BAY 3401016 or a placebo (an inactive substance) during the study.

What does 'proteinuria' mean?

Proteinuria means there is too much protein in your urine, which can be a sign that your kidneys are not working properly.

How long does the study last?

The full duration of your participation, including all follow-up, would be explained by the study team.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

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