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BAY3401016 biomarker testing for Alport syndrome

A Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 2a Study With an Extension Phase to Evaluate the Efficacy and Safety of BAY 3401016 in Participants Aged 18 to 45 With Alport Syndrome

Phase 2 Interventional Bayer · NCT07211685

This trial tests whether BAY 3401016, an antibody that blocks Sema3A, can reduce urine protein and protect kidney function in adults 18–45 with X-linked or autosomal recessive Alport syndrome.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 45 Years
SexAll
SponsorBayer Industry-sponsored
Locations60 sites (Birmingham, Alabama and 59 other locations)
Trial IDNCT07211685 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, placebo-controlled trial of BAY 3401016, a monoclonal antibody that blocks the protein Sema3A, which is implicated in kidney damage in Alport syndrome. Eligible adults (18–45 years) with X-linked or autosomal recessive Alport syndrome, eGFR ≥45 mL/min/1.73m2 and urine albumin-to-creatinine ratio ≥500 mg/g will be enrolled. Participants will receive BAY 3401016 or placebo and undergo regular clinical and biomarker assessments to track changes in proteinuria and kidney function. The study compares treated and placebo groups to see if Sema3A blockade lowers proteinuria and signals slower progression of kidney injury.

Who should consider this trial

Good fit: Adults aged 18 to 45 with genetically consistent X-linked (males) or autosomal recessive Alport syndrome, eGFR ≥45 mL/min/1.73m2, and urine albumin-to-creatinine ratio ≥500 mg/g are the intended participants.

Not a fit: People with other causes of chronic kidney disease, active significant illnesses, a history of malignancy, severe allergies or active skin disorders, uncontrolled blood pressure, or those outside the 18–45 age range are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, BAY 3401016 could lower protein in the urine and slow kidney function decline in people with Alport syndrome.

How similar studies have performed: Blocking Sema3A is a relatively novel approach with supportive preclinical data but limited prior clinical evidence in Alport syndrome.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must be 18 to 45 years of age inclusive
* Participants with AS, either XLAS (male) or ARAS (male or female)
* eGFR ≥ 45 mL/min/1.73m2
* UACR ≥ 500mg/g

Exclusion Criteria:

* Chronic kidney disease is different from AS
* Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives
* History or current existence of malignancy
* 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
* Participants with active skin disorders (e.g. atopic dermatitis, severe acne)
* Systolic blood pressure above 140 mmHg
* Diastolic blood pressure above 90 mmHg

Where this trial is running

Birmingham, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alport Syndrome
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.