BAY 3401016 for Alport Syndrome
(ASSESS Trial)
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.12345Why 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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BAY 3401016 or placebo weekly for 24 weeks in addition to background therapy if eligible
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
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