What is BAY 3401016 studying for Alport syndrome?

BAY 3401016 is being studied for Alport syndrome to see if it can slow down kidney function loss by blocking a protein involved in kidney damage. Researchers want to understand how well this medicine works and its safety in adults with rapidly progressing Alport syndrome. The study is sponsored by Bayer to explore new treatment options for this rare condition.

Who may be eligible for this Alport syndrome clinical trial?

Adults aged 18 to 45 years with a diagnosis of Alport syndrome, including specific genetic types, may be eligible. Participants should have certain kidney function levels and protein in their urine. People with other kidney diseases or severe allergies may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Alport syndrome clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 2

Age: 18Years - 45Years

All Genders

ID07211685

A Randomized, Double-blind, Placebo-controlled Study to Evaluate BAY 3401016 in Adults Aged 18 to 45 With Alport Syndrome

Led by Bayer · Updated on 2026-04-09

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Alport syndrome AS is a rare genetic disorder that affects the kidneys, hearing, and eyes due to changes in specific genes responsible for producing collagen. People with AS face a high risk of chronic kidney disease, where kidney function gradually worsens, often causing excess protein in the urine, called proteinuria. This study aims to evaluate how well BAY 3401016, a monoclonal antibody that blocks the protein Semaphorin 3A involved in kidney damage, works to slow kidney function loss in adults with rapidly progressing AS. Participants will receive either BAY 3401016 or a placebo once a week for 24 weeks, along with their usual background therapy if eligible. The trial is randomized and double-blind, meaning neither participants nor researchers know who receives the study drug or placebo. This is a Phase 2a study with an extension phase to further assess BAY 3401016s effects in adults aged 18 to 45 years. During the study, researchers will measure the urinary albumin creatinine ratio UACR over 16, 20, and 24 weeks of treatment to evaluate kidney function changes. Safety and tolerability of BAY 3401016 will also be monitored throughout the treatment and up to 90 days after the last dose. Participants will have regular assessments to track kidney health and side effects, with the total follow-up lasting beyond the treatment period.

CONDITIONS

Brief Title

BAY3401016; Biomarker Study Alport

Who Can Participate

Age: 18Years - 45Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants must be 18 to 45 years of age inclusive
Diagnosed with Alport syndrome, either XLAS (male) or ARAS (male or female)
Estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m2 or higher
Urinary albumin creatinine ratio (UACR) of 500 mg/g or higher

You will not qualify if you...

Chronic kidney disease not caused by Alport syndrome
Any clinically significant illness affecting participant safety or study objectives
History or current presence of cancer
History of severe allergies, multiple drug allergies, or non-allergic drug reactions including allergic asthma
Active skin disorders such as atopic dermatitis or severe acne
Systolic blood pressure above 140 mmHg
Diastolic blood pressure above 90 mmHg

Research Team

Bayer Clinical Trials Contact

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