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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
Location: See all (58) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Nephrology Clinic at The Kirklin Clinic of UAB Hospital
NOT_YET_RECRUITING
Birmingham
Florida
The Peggy and Harold Katz Family Drug Discovery Center - Nephrology
NOT_YET_RECRUITING
Miami
Georgia
Center for Advanced Pediatrics - Nephrology
NOT_YET_RECRUITING
Atlanta
Idaho
Cardio Renal Institute
RECRUITING
Chubbuck
Massachusetts
Tufts Medical Center | Nephrology Department
NOT_YET_RECRUITING
Boston
Texas
Renal Disease Research Institute | Landry
RECRUITING
Dallas
Other Locations
Argentina
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital Británico
RECRUITING
Ciudad Autonoma De Buenos Aire
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
RECRUITING
San Luis
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.
RECRUITING
Santa Fe
Canada
St. Joseph's Healthcare - Hamilton
RECRUITING
Hamilton
London Health Sciences Centre (LHSC) - University Hospital
NOT_YET_RECRUITING
London
McGill University Health Centre - Glen Site
NOT_YET_RECRUITING
Montreal
Lakeridge Health-Oshawa
NOT_YET_RECRUITING
Oshawa
CHU de Québec-Université Laval
NOT_YET_RECRUITING
Québec
China
Peking University First Hospital - Department of Pediatrics
RECRUITING
Beijing
Children's Hospital of Chongqing Medical University - Department of Nephrology
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics
RECRUITING
Guangzhou
Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology
RECRUITING
Hangzhou
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology
RECRUITING
Wuhan
France
CHU bordeaux - Hopital Pellegrin - Service de Nephrologie-Transplantation-Dialyse-Aphereses
NOT_YET_RECRUITING
Bordeaux
CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation
RECRUITING
Brest
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes
NOT_YET_RECRUITING
Toulouse
Germany
Charité Mitte - Nephrologie und Internistische Intensivmedizin
NOT_YET_RECRUITING
Berlin
Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin
NOT_YET_RECRUITING
Cologne
Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie
RECRUITING
Erlangen
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie
NOT_YET_RECRUITING
Göttingen
India
Mavani Research Center
NOT_YET_RECRUITING
Ahmedabad
K.G. Hospital
NOT_YET_RECRUITING
Coimbatore
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
NOT_YET_RECRUITING
Kolkata
All India Institute of Medical Sciences (AIIMS) - New Delhi
NOT_YET_RECRUITING
New Delhi
Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia
RECRUITING
Brescia
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
RECRUITING
Genova
Ospedale Pediatrico Bambino Gesù - Nefrologia
NOT_YET_RECRUITING
Roma
Japan
Saitama Prefectural Children's Medical Center
RECRUITING
Chuo-ku
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
Japanese RedCross Aichi Medical Center Nagoya Daini Hospital
RECRUITING
Nagoya
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
RECRUITING
Osaka
Poland
CSK U.M. Lodz - Klin. Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnetrznych Samodz. Publiczny Zaklad OZ
NOT_YET_RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Kliniczny Nefrologii Transplantologii i Chorob Wewnetrznych
NOT_YET_RECRUITING
Poznan
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy - Centrum Wsparcia Badan Klinicznych
NOT_YET_RECRUITING
Warsaw
Portugal
Hospital de Curry Cabral - Nephrology Department
NOT_YET_RECRUITING
Lisbon
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Nefrologia
RECRUITING
Porto
Hospital de Torres Novas - Nephrology Department
NOT_YET_RECRUITING
Torres Novas
Unidade Local de Saude de Gaia/Espinho E.P.E Nephrology Department
RECRUITING
Vila Nova De Gaia
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital General La Mancha Centro | Nephrology
NOT_YET_RECRUITING
Alcázar De San Juan
Fundacio Puigvert | Nefrologia
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall D Hebron | Nefrologia
RECRUITING
Barcelona
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia
NOT_YET_RECRUITING
Seville
United Kingdom
Royal Devon University Healthcare NHS Foundation Trust | Royal Devon and Exeter Hospital - Renal Unit
RECRUITING
Exeter
Royal Free London NHS Foundation Trust | Royal Free Hospital - Centre for Nephrology
NOT_YET_RECRUITING
London
Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - Sheffield Kidney Institute
NOT_YET_RECRUITING
Sheffield
South Tyneside and Sunderland NHS Foundation Trust | Sunderland Royal Hospital - Renal Unit
RECRUITING
Sunderland
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2028-07-27
Participants
Target number of participants: 60
Treatments
Experimental: BAY 3401016
BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible
Placebo_comparator: Placebo
Placebo weekly for 24 weeks in addition to background therapy if eligible
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov