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BAY3401016; Biomarker Study Alport
Sponsor: Bayer
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-19
Completion Date
2028-07-27
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
BAY 3401016
BAY 3401016
Placebo
Placebo to BAY 3401016
Locations (60)
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
Center for Advanced Pediatrics - Nephrology
Atlanta, Georgia, 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
Hospital Británico
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, San Luis Province, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.
Santa Fe, Argentina
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, Canada
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, Canada
Lakeridge Health-Oshawa
Oshawa, Ontario, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Canada
Peking University First Hospital - Department of Pediatrics
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University - Department of Nephrology
Chongqing, Chongqing 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
Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology
Hangzhou, Zhejiang, China
Fakultní nemocnice Hradec Kralové - Nefrologická klinika
Hradec Králové, Czechia
Všeobecná fakultní nemocnice v Praze - Klinika nefrologie
Prague, Czechia
CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation
Brest, Brittany Region, France
CHU bordeaux - Hopital Pellegrin - Service de Nephrologie-Transplantation-Dialyse-Aphereses
Bordeaux, Nouvelle-Aquitaine, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes
Toulouse, Occitanie, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte
Paris, Île-de-France Region, France
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie
Göttingen, Lower Saxony, Germany
Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin
Cologne, North Rhine-Westphalia, Germany
Charité Mitte - Nephrologie und Internistische Intensivmedizin
Berlin, Germany
Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie
Erlangen, Germany
Mavani Research Center
Ahmedabad, Gujarat, India
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, National Capital Territory of Delhi, India
K.G. Hospital
Coimbatore, Tamil Nadu, India
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
Kolkata, West Bengal, India
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
Bologna, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia
Brescia, Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genova, Italy
Ospedale Pediatrico Bambino Gesù - Nefrologia
Roma, Italy
Japanese RedCross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Saitama Prefectural Children's Medical Center
Chuo-Ku, Saitama, Japan
Kobe University Hospital
Kobe, Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, Japan
CSK U.M. Lodz - Klin. Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnetrznych Samodz. Publiczny Zaklad OZ
Lodz, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Kliniczny Nefrologii Transplantologii i Chorob Wewnetrznych
Poznan, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy - Centrum Wsparcia Badan Klinicznych
Warsaw, Poland
Hospital de Curry Cabral - Nephrology Department
Lisbon, Portugal
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Nefrologia
Porto, Portugal
Hospital de Torres Novas - Nephrology Department
Torres Novas, Portugal
Unidade Local de Saude de Gaia/Espinho E.P.E Nephrology Department
Vila Nova de Gaia, Portugal
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Hospital General La Mancha Centro | Nephrology
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitari Vall D Hebron | Nefrologia
Barcelona, Spain
Fundacio Puigvert | Nefrologia
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
Madrid, Spain
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia
Seville, Spain
Royal Devon University Healthcare NHS Foundation Trust | Royal Devon and Exeter Hospital - Renal Unit
Exeter, Devon, United Kingdom
Royal Free London NHS Foundation Trust | Royal Free Hospital - Centre for Nephrology
London, Greater London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - Sheffield Kidney Institute
Sheffield, South Yorkshire, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust | Sunderland Royal Hospital - Renal Unit
Sunderland, Tyne and Wear, United Kingdom