Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-12-02
2028-07-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BAY 3401016
BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible
BAY 3401016
BAY 3401016
Placebo
Placebo weekly for 24 weeks in addition to background therapy if eligible
Placebo
Placebo to BAY 3401016
Interventions
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BAY 3401016
BAY 3401016
Placebo
Placebo to BAY 3401016
Eligibility Criteria
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Inclusion Criteria
* Participants with AS, either XLAS (male) or ARAS (male or female)
* eGFR ≥ 45 mL/min/1.73m2
* UACR ≥ 500mg/g
Exclusion Criteria
* 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
18 Years
45 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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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, Quebec, 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 bordeaux - Hopital Pellegrin - Service de Nephrologie-Transplantation-Dialyse-Aphereses
Bordeaux, , France
CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation
Brest, , France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte
Paris, , France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes
Toulouse, , 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
K.G. Hospital
Coimbatore, , India
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
Kolkata, , India
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, , 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
ULS São João - Nephrology Department
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 La Mancha Centro_Nephrology
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitari Vall d´Hebron_ Nefrologia
Barcelona, , Spain
Fundació Puigvert Enfermedades Renales Hereditarias. Servicio de Nefrología
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
Madrid, , Spain
Hospital Universitario Virgen del Rocio_Nephrology
Seville, , Spain
South Tyneside and Sunderland NHS Foundation Trust | Sunderland Royal Hospital - Renal Unit
Sunderland, Tyne and Wear, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust | Royal Devon and Exeter Hospital - Renal Unit
Exeter, , United Kingdom
Royal Free London NHS Foundation Trust | Royal Free Hospital - Centre for Nephrology
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - Sheffield Kidney Institute
Sheffield, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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22419
Identifier Type: -
Identifier Source: org_study_id
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