A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Alport Syndrome
In brief
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.
Key facts
- Study ID
- NCT07211685
- Run by
- Bayer
- People needed
- 60
- Starts
- 2025-11-19
- Expected to finish
- 2028-07-27
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie — Erlangen, Bavaria, Germany (enrolling)
- The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital) — Kolkata, West Bengal, India (enrolling)
- Nephrology Clinic at The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States (enrolling)
- Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte — Paris, Île-de-France Region, France (enrolling)
- K.G. Hospital — Coimbatore, Tamil Nadu, India (enrolling)
- Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A. — Santa Fe, Santa Fe Province, Argentina (enrolling)
- Cardio Renal Institute — Chubbuck, Idaho, United States (enrolling)
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) — Buenos Aires, Argentina (enrolling)
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentina — San Luis, Argentina (enrolling)
- Tufts Medical Center | Nephrology Department — Boston, Massachusetts, United States (enrolling)
- Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie — Göttingen, Lower Saxony, Germany (enrolling)
- Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin — Cologne, North Rhine-Westphalia, Germany (enrolling)
- Montreal General Hospital | Nephrology — Montreal, Quebec, Canada (enrolling)
- Centre hospitalier universitaire de Québec (CHUQ) | Nephrology — Québec, Canada (enrolling)
- Peking University First Hospital - Department of Pediatrics — Beijing, Beijing Municipality, China (enrolling)
- Hospital Británico — Buenos Aires, Argentina (enrolling)
- The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics — Guangzhou, Guangdong, China (enrolling)
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology — Wuhan, Hubei, China (enrolling)
- Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology — Hangzhou, Zhejiang, China (enrolling)
- Fakultní nemocnice Hradec Kralové - Nefrologická klinika — Hradec Králové, Hradec Králové Region, Czechia (enrolling)
- St Joseph's Healthcare Hamilton | Cardiology — Hamilton, Ontario, Canada (enrolling)
- CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation — Brest, Brittany Region, France (enrolling)
- Renal Disease Research Institute | Landry — Dallas, Texas, United States (enrolling)
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes — Toulouse, Occitanie, France (enrolling)
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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