Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate BAY 3401016 in Adults Aged 18 to 45 With Alport Syndrome
Led by Bayer · Updated on 2026-04-09
60
Participants Needed
60
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Alport syndrome (AS) is a rare genetic disorder that affects the kidneys, hearing, and eyes due to changes in specific genes responsible for producing collagen. People with AS face a high risk of chronic kidney disease, where kidney function gradually worsens, often causing excess protein in the urine, called proteinuria. This study aims to evaluate how well BAY 3401016, a monoclonal antibody that blocks the protein Semaphorin 3A involved in kidney damage, works to slow kidney function loss in adults with rapidly progressing AS. Participants will receive either BAY 3401016 or a placebo once a week for 24 weeks, along with their usual background therapy if eligible. The trial is randomized and double-blind, meaning neither participants nor researchers know who receives the study drug or placebo. This is a Phase 2a study with an extension phase to further assess BAY 3401016's effects in adults aged 18 to 45 years. During the study, researchers will measure the urinary albumin creatinine ratio (UACR) over 16, 20, and 24 weeks of treatment to evaluate kidney function changes. Safety and tolerability of BAY 3401016 will also be monitored throughout the treatment and up to 90 days after the last dose. Participants will have regular assessments to track kidney health and side effects, with the total follow-up lasting beyond the treatment period.
CONDITIONS
Brief Title
BAY3401016; Biomarker Study Alport
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 to 45 years of age inclusive
- Diagnosed with Alport syndrome, either XLAS (male) or ARAS (male or female)
- Estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m2 or higher
- Urinary albumin creatinine ratio (UACR) of 500 mg/g or higher
You will not qualify if you...
- Chronic kidney disease not caused by Alport syndrome
- Any clinically significant illness affecting participant safety or study objectives
- History or current presence of cancer
- History of severe allergies, multiple drug allergies, or non-allergic drug reactions including allergic asthma
- Active skin disorders such as atopic dermatitis or severe acne
- Systolic blood pressure above 140 mmHg
- Diastolic blood pressure above 90 mmHg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive weekly doses of BAY 3401016 or placebo for 24 weeks in addition to their background therapy if eligible.
Weekly visits for up to 24 weeks
Duration - Approximately 3 months
Participants are monitored for safety and tolerability for approximately 90 days after treatment ends.
1 follow-up visit about 90 days after end of treatment
Trial Site Locations
Total: 60 locations
1
Nephrology Clinic at The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
The Peggy and Harold Katz Family Drug Discovery Center - Nephrology
Miami, Florida, United States, 33136
Not Yet Recruiting
3
Center for Advanced Pediatrics - Nephrology
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
4
Cardio Renal Institute
Chubbuck, Idaho, United States, 83202
Actively Recruiting
5
Tufts Medical Center | Nephrology Department
Boston, Massachusetts, United States, 02111
Not Yet Recruiting
6
Renal Disease Research Institute | Landry
Dallas, Texas, United States, 75246
Actively Recruiting
7
Hospital Británico
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1280AEB
Actively Recruiting
8
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1431FWO
Actively Recruiting
9
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, San Luis Province, Argentina, D5700CGR
Actively Recruiting
10
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A.
Santa Fe, Argentina, S3000EPV
Actively Recruiting
11
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
12
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, Canada, N6A 5A5
Not Yet Recruiting
13
Lakeridge Health-Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Not Yet Recruiting
14
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
15
CHU de Québec-Université Laval
Québec, Canada, G1R 2J6
Not Yet Recruiting
16
Peking University First Hospital - Department of Pediatrics
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
17
Children's Hospital of Chongqing Medical University - Department of Nephrology
Chongqing, Chongqing Municipality, China, 401122
Not Yet Recruiting
18
The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics
Guangzhou, Guangdong, China, 510080
Actively Recruiting
19
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology
Wuhan, Hubei, China, 430205
Actively Recruiting
20
Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
21
Fakultní nemocnice Hradec Kralové - Nefrologická klinika
Hradec Králové, Czechia, 500 05
Actively Recruiting
22
Všeobecná fakultní nemocnice v Praze - Klinika nefrologie
Prague, Czechia, 128 08
Not Yet Recruiting
23
CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation
Brest, Brittany Region, France, 29200
Actively Recruiting
24
CHU bordeaux - Hopital Pellegrin - Service de Nephrologie-Transplantation-Dialyse-Aphereses
Bordeaux, New Aquitaine, France, 33076
Not Yet Recruiting
25
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes
Toulouse, Occitanie, France, 31400
Not Yet Recruiting
26
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte
Paris, Île-de-France Region, France, 75015
Not Yet Recruiting
27
Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie
Göttingen, Lower Saxony, Germany, 37075
Not Yet Recruiting
28
Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin
Cologne, North Rhine-Westphalia, Germany, 50937
Not Yet Recruiting
29
Charité Mitte - Nephrologie und Internistische Intensivmedizin
Berlin, Germany, 10117
Not Yet Recruiting
30
Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie
Erlangen, Germany, 91054
Actively Recruiting
31
Mavani Research Center
Ahmedabad, Gujarat, India, 380052
Not Yet Recruiting
32
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, National Capital Territory of Delhi, India, 110029
Not Yet Recruiting
33
K.G. Hospital
Coimbatore, Tamil Nadu, India, 641018
Not Yet Recruiting
34
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
Kolkata, West Bengal, India, 700020
Not Yet Recruiting
35
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
Bologna, Italy, 40138
Actively Recruiting
36
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia
Brescia, Italy, 25123
Actively Recruiting
37
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genova, Italy, 16147
Actively Recruiting
38
Ospedale Pediatrico Bambino Gesù - Nefrologia
Roma, Italy, 00165
Not Yet Recruiting
39
Japanese RedCross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan, 466-8650
Actively Recruiting
40
Saitama Prefectural Children's Medical Center
Chuo-Ku, Saitama, Japan, 330-8777
Actively Recruiting
41
Kobe University Hospital
Kobe, Japan, 650-0017
Not Yet Recruiting
42
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, Japan, 534-0021
Actively Recruiting
43
CSK U.M. Lodz - Klin. Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnetrznych Samodz. Publiczny Zaklad OZ
Lodz, Poland, 92-213
Not Yet Recruiting
44
Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Kliniczny Nefrologii Transplantologii i Chorob Wewnetrznych
Poznan, Poland, 60-355
Not Yet Recruiting
45
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy - Centrum Wsparcia Badan Klinicznych
Warsaw, Poland, 04-141
Not Yet Recruiting
46
Hospital de Curry Cabral - Nephrology Department
Lisbon, Portugal, 1069-166
Not Yet Recruiting
47
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Nefrologia
Porto, Portugal, 4200-319
Actively Recruiting
48
Hospital de Torres Novas - Nephrology Department
Torres Novas, Portugal, 2350-399
Not Yet Recruiting
49
Unidade Local de Saude de Gaia/Espinho E.P.E Nephrology Department
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
50
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea, 13620
Actively Recruiting
51
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
52
Hospital General La Mancha Centro | Nephrology
Alcázar de San Juan, Ciudad Real, Spain, 13600
Not Yet Recruiting
53
Hospital Universitari Vall D Hebron | Nefrologia
Barcelona, Spain, 08035
Actively Recruiting
54
Fundacio Puigvert | Nefrologia
Barcelona, Spain, 8025
Not Yet Recruiting
55
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
Madrid, Spain, 28040
Actively Recruiting
56
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia
Seville, Spain, 41013
Not Yet Recruiting
57
Royal Devon University Healthcare NHS Foundation Trust | Royal Devon and Exeter Hospital - Renal Unit
Exeter, Devon, United Kingdom, EX2 5DW
Actively Recruiting
58
Royal Free London NHS Foundation Trust | Royal Free Hospital - Centre for Nephrology
London, Greater London, United Kingdom, NW3 2QG
Not Yet Recruiting
59
Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - Sheffield Kidney Institute
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Not Yet Recruiting
60
South Tyneside and Sunderland NHS Foundation Trust | Sunderland Royal Hospital - Renal Unit
Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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