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NCT07211685PHASE2Recruiting

A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome

Bayer

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

BIOLOGICAL

BAY 3401016

OTHER

Placebo

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Conditions

Alport Syndrome

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