NCT07211685

BAY3401016; Biomarker Study Alport

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. 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 study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS.

Conditions

• Alport Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	BAY 3401016	BAY 3401016
OTHER	Placebo	Placebo to BAY 3401016

Timeline

• Start date: 2025-11-19
• Primary completion: 2028-07-27
• Completion: 2028-07-27
• First posted: 2025-10-08
• Last updated: 2026-04-09

Locations

60 sites across 15 countries: United States, Argentina, Canada, China, Czechia, France, Germany, India, Italy, Japan, Poland, Portugal, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study