What this means
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.
A plain-English summary is on its way. Until then, this is the start of the registry's own summary.
- Status
- Active not recruiting
- Who can join
- Ages 18–45
- Where
- 51 sites, including Alabama, Florida, Idaho
The science
- Registered title
- A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
- Trial ID
- NCT07211685 ↗
- Phase
- PHASE 2
- Study type
- interventional
- Conditions
- Alport Syndrome
- What is tested
- BAY 3401016, Placebo
- Sponsor
- Bayer
- Ages
- 18 Years to 45 Years
- Dates
- First posted Oct 8, 2025 · updated Oct 29, 2026
Registry 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.
Sites (51)
- Nephrology Clinic at The Kirklin Clinic of UAB Hospital, Birmingham, Alabama, United States
- The Peggy and Harold Katz Family Drug Discovery Center - Nephrology, Miami, Florida, United States
- Cardio Renal Institute, Chubbuck, Idaho, United States
- Tufts Medical Center | Nephrology Department, Boston, Massachusetts, United States
- Renal Disease Research Institute | Landry, Dallas, Texas, United States
- Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A., Santa Fe, Santa Fe Province, Argentina
- Hospital Británico, Buenos Aires, Argentina
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC), Buenos Aires, Argentina
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentina, San Luis, Argentina
- St Joseph's Healthcare Hamilton | Cardiology, Hamilton, Ontario, Canada
- Montreal General Hospital | Nephrology, Montreal, Quebec, Canada
- Centre hospitalier universitaire de Québec (CHUQ) | Nephrology, Québec, Canada
- Peking University First Hospital - Department of Pediatrics, Beijing, Beijing Municipality, China
- The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics, Guangzhou, Guangdong, China
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology, Wuhan, Hubei, China
Related treatments
More aging trials in these states
Alabama · Florida · Idaho · Massachusetts · Texas