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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

5 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

BAY 3401016 – BAY 3401016 is an experimental medication currently being tested in clinical trials and is not yet approved for general medical use. It is being studied as a potential treatment for Alport Syndrome, a genetic condition that affects the kidneys and can lead to chronic kidney disease. The drug is administered in a form and dosage that is being evaluated during the Phase 2a trial to determine its safety and effectiveness. The main goal of the study is to see if BAY 3401016 can reduce the amount of protein in the urine (a condition called albuminuria), which is a key sign of kidney damage in people with Alport Syndrome, though the exact way the medication works at the molecular level has not been publicly disclosed at this stage of research.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516471-33-00Protocol code22419Estimated enrolment60 patientsSponsorBayer AG

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