A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
Start Date
11/19/2025
Completion Date
7/27/2028
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.
Eligibility Criteria
Age Range: 18 years to 45 years
Interventions
BAY 3401016
Placebo
Conditions
Locations
Nephrology Clinic at The Kirklin Clinic of UAB Hospital
Birmingham, Alabama 35233
United States
The Peggy and Harold Katz Family Drug Discovery Center - Nephrology
Miami, Florida 33136
United States
Center for Advanced Pediatrics - Nephrology
Atlanta, Georgia 30329
United States
Cardio Renal Institute
Chubbuck, Idaho 83202
United States
Tufts Medical Center | Nephrology Department
Boston, Massachusetts 02111
United States
Renal Disease Research Institute | Landry
Dallas, Texas 75246
United States
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.
Santa Fe, Santa Fe Province S3000EPV
Argentina
Hospital Británico
Buenos Aires, C1280AEB
Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO
Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, D5700CGR
Argentina
St Joseph's Healthcare Hamilton | Cardiology
Hamilton, Ontario L8N 4A6
Canada
University Hospital | Nephrology
London, Ontario N6A 5A5
Canada
Lakeridge Health | Nephrology
Whitby, Ontario L1N 5T2
Canada
Montreal General Hospital | Nephrology
Montreal, Quebec H4A 3J1
Canada
Centre hospitalier universitaire de Québec (CHUQ) | Nephrology
Québec, G1R 2J6
Canada
Peking University First Hospital - Department of Pediatrics
Beijing, Beijing Municipality 100000
China
Children's Hospital of Chongqing Medical University - Department of Nephrology
Chongqing, Chongqing Municipality 401122
China
The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics
Guangzhou, Guangdong 510080
China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology
Wuhan, Hubei 430205
China
Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology
Hangzhou, Zhejiang 310052
China
Fakultní nemocnice Hradec Kralové - Nefrologická klinika
Hradec Králové, Hradec Králové Region 500 05
Czechia
Všeobecná fakultní nemocnice v Praze - Klinika nefrologie
Prague, Prague 128 08
Czechia
CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation
Brest, Brittany Region 29200
France
CHU bordeaux - Hopital Pellegrin - Service de Nephrologie-Transplantation-Dialyse-Aphereses
Bordeaux, New Aquitaine 33076
France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes
Toulouse, Occitanie 31400
France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte
Paris, Île-de-France Region 75015
France
Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie
Erlangen, Bavaria 91054
Germany
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie
Göttingen, Lower Saxony 37075
Germany
Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin
Cologne, North Rhine-Westphalia 50937
Germany
Charité Mitte - Nephrologie und Internistische Intensivmedizin
Berlin, 10117
Germany
Mavani Research Center
Ahmedabad, Gujarat 380052
India
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, National Capital Territory of Delhi 110029
India
K.G. Hospital
Coimbatore, Tamil Nadu 641018
India
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
Kolkata, West Bengal 700020
India
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
Bologna, 40138
Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia
Brescia, 25123
Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genova, 16147
Italy
Ospedale Pediatrico Bambino Gesù - Nefrologia
Roma, 00165
Italy
Japanese RedCross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken 466-8650
Japan
Kobe University Hospital
Kobe, Hyōgo 650-0017
Japan
Saitama Prefectural Children's Medical Center
Chuo-Ku, Tokyo 330-8777
Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, 534-0021
Japan
CSK U.M. Lodz - Klin. Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnetrznych Samodz. Publiczny Zaklad OZ
Lodz, 92-213
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu - Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Poznan, 60-355
Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy - Centrum Wsparcia Badan Klinicznych
Warsaw, 04-141
Poland
Hospital de Curry Cabral - Nephrology Department
Lisbon, 1069-166
Portugal
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Nefrologia
Porto, 4200-319
Portugal
Hospital de Torres Novas - Nephrology Department
Torres Novas, 2350-399
Portugal
Unidade Local de Saude de Gaia/Espinho E.P.E Nephrology Department
Vila Nova de Gaia, 4434-502
Portugal
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Hospital General La Mancha Centro | Nephrology
Alcázar de San Juan, Ciudad Real 13600
Spain
Hospital Universitari Vall D Hebron | Nefrologia
Barcelona, 08035
Spain
Fundacio Puigvert | Nefrologia
Barcelona, 8025
Spain
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
Madrid, 28040
Spain
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia
Seville, 41013
Spain
Royal Devon University Healthcare NHS Foundation Trust | Royal Devon and Exeter Hospital - Renal Unit
Exeter, Devon EX2 5DW
United Kingdom
Royal Free London NHS Foundation Trust | Royal Free Hospital - Centre for Nephrology
London, Greater London NW3 2QG
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - Sheffield Kidney Institute
Sheffield, South Yorkshire S5 7AU
United Kingdom
South Tyneside and Sunderland NHS Foundation Trust | Sunderland Royal Hospital - Renal Unit
Sunderland, Tyne and Wear SR4 7TP
United Kingdom