BAY 3401016 for Alport Syndrome

(ASSESS Trial)

Not yet recruiting at 59 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Bayer

Disqualifiers: Malignancy, Severe allergies, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new medicine, BAY 3401016, can slow kidney damage in individuals with Alport Syndrome, a genetic condition affecting the kidneys, hearing, and eyes. Alport Syndrome often leads to protein in the urine and eventual kidney failure. The study will compare BAY 3401016 to a placebo to assess its effectiveness. Individuals with Alport Syndrome who experience protein in their urine and have not yet reached severe kidney failure may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BAY 3401016 is likely to be safe for humans?

Research has shown that BAY 3401016 has undergone human testing, indicating a positive safety profile. In those earlier studies, most participants tolerated the treatment well, experiencing no severe side effects. However, specific details about adverse reactions were not provided in the sources.

BAY 3401016 is currently in a phase where researchers are examining its efficacy and safety. They are focusing on its effectiveness, beyond just assessing safety. Discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Alport Syndrome, which typically focus on managing symptoms and slowing kidney damage, BAY 3401016 represents a novel approach. Researchers are excited because BAY 3401016 potentially targets the underlying genetic cause of the disease, offering a more direct intervention. This experimental treatment could pave the way for more effective management of Alport Syndrome, potentially improving outcomes for patients by addressing the root of the condition rather than just its symptoms.

What evidence suggests that BAY 3401016 might be an effective treatment for Alport syndrome?

Research suggests that BAY 3401016, which participants in this trial may receive, might help treat Alport syndrome by targeting a protein called Semaphorin 3A (Sema3A). This protein likely contributes to kidney damage in the condition. By blocking Sema3A, BAY 3401016 may help reduce proteinuria, a condition where excess protein in the urine signals worsening kidney function. Early results indicate that BAY 3401016 could slow the loss of kidney function in people with Alport syndrome. Although researchers are still studying this treatment, it shows promise based on its intended mechanism. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults with rapidly progressing Alport Syndrome, a genetic condition leading to kidney disease and other issues. Participants must have specific gene changes responsible for AS and are at high risk of chronic kidney disease. Details on inclusion or exclusion criteria were not provided.

Inclusion Criteria

eGFR ≥ 45 mL/min/1.73m2

UACR ≥ 500mg/g

I have Alport Syndrome, either X-linked (if male) or autosomal recessive.

Exclusion Criteria

Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids or urticaria

Chronic kidney disease is different from AS

Systolic blood pressure above 140 mmHg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BAY 3401016 or placebo weekly for 24 weeks in addition to background therapy if eligible

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Extension

Participants may continue to receive the study drug in an open-label extension phase

What Are the Treatments Tested in This Trial?

Interventions

• BAY 3401016

Trial Overview

The trial is testing BAY 3401016, a monoclonal antibody that blocks Sema3A protein thought to cause kidney damage in Alport Syndrome. It aims to see if the drug can reduce proteinuria and slow down kidney function loss compared to a placebo.

How Is the Trial Designed?

Group I: BAY 3401016 Experimental Treatment 1 Intervention

BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible

Group II: Placebo Placebo Group 1 Intervention

Placebo weekly for 24 weeks in addition to background therapy if eligible

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07211685

NCT07211685 | BAY3401016; Biomarker Study Alport

By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS. The main purpose of this ...

2.

clinicaltrials.bayer.com

clinicaltrials.bayer.com/study/22419

Alport syndrome | Study 22419

The main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly ...

3.

tipranks.com

tipranks.com/news/company-announcements/bayer-ags-new-study-on-alport-syndrome-a-potential-game-changer

Bayer AG's New Study on Alport Syndrome

' This study aims to assess the effectiveness of BAY 3401016 in slowing kidney function loss in adults with Alport Syndrome, a rare genetic ...

4.

fortunebusinessinsights.com

fortunebusinessinsights.com/alport-syndrome-pipeline-112977

Alport Syndrome – Pipeline Review, 2025

The report on alport syndrome – Pipeline Review, 2025 provides a comprehensive overview of the drugs that are in the R&D pipeline by indication or molecule.

5.

barchart.com

barchart.com/story/news/35019230/alport-syndrome-pipeline-2025-groundbreaking-clinical-advancements-by-4-global-leaders-delveinsight-featuring-enyo-pharma-bayer-zyversa-therapeutics

Alport syndrome Pipeline 2025: Groundbreaking Clinical ...

BAY 3401016, also known as SEMA 3A, is a monoclonal antibody developed by Bayer in collaboration with Evotec SE. It targets semaphorin 3A ( ...

6.

withpower.com

withpower.com/trial/phase-2-nephritis-hereditary-8-2025-2cb13

BAY 3401016 for Alport Syndrome · Info for Participants

Prior Safety DataThis treatment has passed at least one previous human trial. What You Need to Know Before You Apply. What is the purpose of this trial ...

7.

synapse.patsnap.com

synapse.patsnap.com/drug/7472230d200f47ea810b7c4a5392331e

BAY-3401016 - Drug Targets, Indications, Patents

... Safety of BAY 3401016 in Participants Aged 18 to 45 With Alport Syndrome ... Synapse data is also accessible to external entities via APIs or data packages.