A Study Testing How Well BAY 3401016 Works and How Safe It Is in Adults Aged 18 to 45 Years with Alport Syndrome

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What is this study about?

This study is looking at Alport syndrome, a condition that affects the kidneys and can lead to chronic kidney disease. Alport syndrome is an inherited disorder that damages the tiny blood vessels in the kidneys, causing them to work less effectively over time. This can result in protein leaking into the urine, a condition called albuminuria. The study will test a medication called BAY 3401016, which is given as a solution for injection. Some participants will receive BAY 3401016 while others will receive placebo. The purpose of the study is to assess the effect of BAY 3401016 on albuminuria in participants with Alport syndrome.

The study is designed as a randomized, double-blind, placebo-controlled trial with an extension phase. This means that participants will be assigned by chance to receive either the study medication or placebo, and neither the participants nor the doctors will know which treatment is being given during the main part of the study. The study will involve adults between 18 and 45 years of age who have been diagnosed with Alport syndrome. Participants will need to have certain levels of kidney function and protein in their urine to take part. They will also need to be taking certain medications for their kidneys, specifically medicines known as ACE inhibitors or ARBs, which are commonly used to help protect the kidneys.

During the study, measurements will be taken to see how the treatment affects the amount of protein in the urine over time. The main focus will be on measuring the ratio of protein in the urine at specific time points during the treatment period, specifically at 16, 20, and 24 weeks. The study will also monitor participants for any unwanted effects or side effects that may occur during treatment. After the main treatment period, there will be an extension phase where participants may continue to be followed to gather more information about the long-term effects of the medication.

1 Treatment assignment

You will be randomly assigned to receive either BAY 3401016 or placebo. The placebo is an inactive substance that looks like the actual medication but contains no active ingredient.

This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving during the study.

2 Initial treatment phase

You will receive your assigned treatment for 24 weeks.

The medication will be administered as a solution for injection.

During this phase, you will continue taking your current medications for Alport syndrome, which include ACE inhibitors (medications that help lower blood pressure and reduce protein in urine) and/or ARB (angiotensin receptor blockers, another type of blood pressure medication).

3 Regular assessments during initial treatment

Your urine will be tested regularly to measure the amount of protein being lost. This is measured using a test called UACR (urine albumin-to-creatinine ratio).

Specific assessments will be conducted at 16 weeks, 20 weeks, and 24 weeks of treatment to evaluate how well the medication is working.

Your kidney function will be monitored through blood tests that measure eGFR (estimated glomerular filtration rate), which indicates how well your kidneys are filtering waste from your blood.

4 Safety monitoring

Throughout the study, you will be monitored for any side effects or adverse reactions to the treatment.

Any health changes or problems that occur during the study will be recorded and evaluated by the medical team.

5 Extension phase

After completing the initial 24-week treatment phase, you may be eligible to continue in an extension phase of the study.

The extension phase will allow for longer-term evaluation of the treatment’s effects and safety.

Who Can Join the Study?

You must be between 18 and 45 years old
You must have Alport Syndrome, which is an inherited condition that affects the kidneys and can cause kidney damage over time
If you are male, you can have either the X-linked form (passed through the X chromosome) or the autosomal recessive form (inherited from both parents) of Alport Syndrome
If you are female, you must have the autosomal recessive form of Alport Syndrome
Your eGFR (a blood test that measures how well your kidneys are filtering waste) must be 45 or higher. This number is measured in milliliters per minute per body surface area
Your UACR (a urine test that measures the amount of a protein called albumin in your urine compared to creatinine) must be 500 or higher. This number is measured in milligrams per gram
You must already be taking medication called ACE inhibitors or ARBs, which are blood pressure medicines that also help protect the kidneys

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed information about what would prevent someone from joining this study, it is not possible to list the specific conditions or situations that would make a person ineligible
The study focuses on Alport Syndrome, which is a genetic condition affecting the kidneys, and chronic kidney disease, which is long-term damage to the kidneys
The study accepts both male and female participants
The study includes adults as participants, based on the age category information provided

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Fundacio Puigvert	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Ubdojbjjho Hjgvclch Cjmmaph	Cologne	Germany
Avxkqjj Uxryd Snuzznovo Lmikug Dr Bkqswka	Bologna	Italy
Hyirkdja Veie dmfrlmjh	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	06.02.2026
France	Recruiting	06.02.2026
Germany	Recruiting	06.02.2026
Italy	Recruiting	06.02.2026
Poland	Recruiting	06.02.2026
Portugal	Recruiting	06.02.2026
Spain	Recruiting	06.02.2026

Trial locations

BAY 3401016 is an investigational medication being tested in this clinical trial. It is being studied to see if it can help reduce protein in the urine (a condition called albuminuria) in people with Alport syndrome, which is a genetic kidney disease. This medication is still being researched and is not yet approved for general use.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of BAY 3401016 against no treatment, helping researchers understand if the medication actually works.

Investigated diseases:

Chronic kidney disease – Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood over time. The disease develops slowly, often over several years, and may not cause noticeable symptoms in its early stages. As the condition progresses, waste products and fluids can build up in the body, leading to various health problems. The kidneys become less efficient at maintaining the body’s chemical balance and removing toxins. This ongoing decline in kidney function can advance through different stages, from mild damage to severe loss of kidney function. The progression rate varies among individuals and depends on the underlying cause and other health factors.

Alport syndrome – Alport syndrome is an inherited disorder that affects the kidneys, hearing, and eyes due to abnormalities in certain proteins that form part of the body’s connective tissues. The condition primarily damages the tiny blood vessels in the kidneys called glomeruli, which are responsible for filtering waste from the blood. Over time, this damage leads to blood and protein leaking into the urine, a condition known as hematuria and proteinuria. The disease typically begins in childhood or early adulthood and progressively worsens as the kidney filtering units become increasingly scarred. Many individuals with Alport syndrome also develop hearing loss and eye abnormalities as the disease affects similar protein structures in these organs. The rate of progression can vary depending on the specific genetic mutation and the type of inheritance pattern.

Trial ID:

2024-516471-33-00

Protocol code:

22419

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study Testing How Well BAY 3401016 Works and How Safe It Is in Adults Aged 18 to 45 Years with Alport Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?