Clinical trial • Phase II • Rare Disease|Nephrology
BAY 3401016 for Alport syndrome|Chronic kidney disease
Phase II trial of BAY 3401016 for Alport syndrome|Chronic kidney disease.
Overview
- Trial Therapeutic Area
- Rare Disease|Nephrology
- Trial Disease
- Alport syndrome|Chronic kidney disease
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 15-08-2025
- First CTIS Authorization Date
- 05-12-2025
Trial design
Randomised, placebo to bay 3401016 (matching placebo) and bay 3401016 (active). dose and schedule not specified in available data.-controlled Phase II trial across 27 sites in Czechia, Germany, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo to BAY 3401016 (matching placebo) and BAY 3401016 (active). Dose and schedule not specified in available data.
- Target Sample Size
- 29
Eligibility
Recruits 29 adults.
Inclusion criteria
- {"criterion_text":"- Participants must be 18 to 45 years of age inclusive\n- Participants with AS, either XLAS (male) or ARAS (male or female)\n- eGFR ≥ 45 mL/min/1.73m2\n- UACR ≥ 500mg/g\n- Treatment with ACEi and/or ARB"}
Exclusion criteria
- {"criterion_text":"- Chronic kidney disease is different from AS\n- Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives\n- History or current existence of malignancy\n- 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\n- Participants with active skin disorders (e.g. atopic dermatitis, severe acne)\n- Systolic blood pressure above 140 mmHg\n- Diastolic blood pressure above 90 mmHg"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment","definition_or_measurement_approach":"Mean urinary albumin-to-creatinine ratio (UACR) expressed as ratio to baseline, averaged across measurements at weeks 16, 20 and 24 of treatment"}
Secondary endpoints
- {"endpoint_text":"- Number of participants with TEAEs and TESAEs","definition_or_measurement_approach":"Count of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) as reported during the study"}
Recruitment
- Digital Remote Recruitment
- True, recruitment materials include website pages/screenshots and online advertising banners used in country-specific recruitment documents (documents available for DE, ES, IT, PT, PL, FR, CZ).
- Planned Sample Size
- 29
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent is obtained from adult participants (trial includes participants aged 18–45). Subject information and informed consent form (L1_SIS_and_ICF_Core and country-specific ICFs) are provided in multiple languages (documents available in CZ (Czech), DE (German), EN (English), ES (Spanish), IT (Italian), PL (Polish), PT (Portuguese), FR (French)). Additional ICF documents addressing expecting parents and pharmacogenetic research are provided where applicable. Specific assent procedures are not described in the available documents.
Methods
- K1_Recruitment_arrangements (country-specific) – documents present for Czechia (associatedEntityId 260247), Germany (262059), Spain (261526), Poland (259164), Italy (265732), France (265887) and Portugal (265896).
- Study leaflets (K2_Recruitment_material_Public_Study_Leaflet) – country-specific versions present (e.g. CZ, IT, ES, PL, FR, PT).
- Advertising banners (K2_Recruitment_material_Public_Advertising_Banners / Banners) – country-specific versions present (e.g. CZ, DE, ES, PL, IT, FR, PT).
- Website pages/screenshots (K2_Recruitment_material_Public_Website / Website_Screenshots / Website_Page) – country-specific web materials available for Germany, Spain, Italy, Portugal, Poland and others.
- ICF tabletop / Tabletop materials (K2_Recruitment_material_Public_ICF_Tabletop) – country-specific versions present.
- Welcome booklet and study welcome materials (Germany: K2_Recruitment_material_Public_Welcome_Booklet_DE_DE).
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 31
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-11-2025
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Klinika nefrologie
- Principal Investigator Name
- Vladimir Tesar
- Principal Investigator Email
- nefroambulance@vfn.cz
- Contact Person Name
- Vladimir Tesar
- Contact Person Email
- nefroambulance@vfn.cz
- Number Of Participants
- 0
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Nefrologická klinika
- Principal Investigator Name
- Roman Safranek
- Principal Investigator Email
- roman.safranek@fnhk.cz
- Contact Person Name
- Roman Safranek
- Contact Person Email
- roman.safranek@fnhk.cz
- Number Of Participants
- 0
Germany
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 13
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik fuer Nephrologie und Rheumatologie
- Principal Investigator Name
- Oliver Gross
- Principal Investigator Email
- gross.oliver@med.uni-goettingen.de
- Contact Person Name
- Oliver Gross
- Contact Person Email
- gross.oliver@med.uni-goettingen.de
- Number Of Participants
- 0
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Nephrologie und Internistische Intensivmedizin
- Principal Investigator Name
- Jan Halbritter
- Principal Investigator Email
- jan.halbritter@charite.de
- Contact Person Name
- Jan Halbritter
- Contact Person Email
- jan.halbritter@charite.de
- Number Of Participants
- 0
- Site Name
- University Hospital Cologne AöR
- Department Name
- Nephrologie, Rheumatologie, Diabetologie, Innere Medizin
- Principal Investigator Name
- Roman-Ulrich Mueller
- Principal Investigator Email
- roman-ulrich.mueller@uk-koeln.de
- Contact Person Name
- Roman-Ulrich Mueller
- Contact Person Email
- roman-ulrich.mueller@uk-koeln.de
- Number Of Participants
- 0
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Nephrologie, Hypertensiologie
- Principal Investigator Name
- Michael Wiesener
- Principal Investigator Email
- michael.wiesener@uk-erlangen.de
- Contact Person Name
- Michael Wiesener
- Contact Person Email
- michael.wiesener@uk-erlangen.de
- Number Of Participants
- 0
Spain
- Earliest CTIS Part Ii Submission Date
- 26-11-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 14
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Nephrology
- Principal Investigator Name
- Manuel López Mendoza
- Principal Investigator Email
- manuel.lopez.mendoza.sspa@juntadeandalucia.es
- Contact Person Name
- Manuel López Mendoza
- Contact Person Email
- manuel.lopez.mendoza.sspa@juntadeandalucia.es
- Number Of Participants
- 0
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Nephrology and Hypertension Department
- Principal Investigator Name
- Maria Vanessa Perez Gomez
- Principal Investigator Email
- fjd@fjd.es
- Contact Person Name
- Maria Vanessa Perez Gomez
- Contact Person Email
- fjd@fjd.es
- Number Of Participants
- 0
- Site Name
- Fundacio Puigvert
- Department Name
- Servicio de Nefrología
- Principal Investigator Name
- Mónica María Furlano
- Principal Investigator Email
- barcelonacentreprivat@fundacio-puigvert.es
- Contact Person Name
- Mónica María Furlano
- Contact Person Email
- barcelonacentreprivat@fundacio-puigvert.es
- Number Of Participants
- 0
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Nefrologia
- Principal Investigator Name
- Laia Sans
- Principal Investigator Email
- web@vallhebron.cat
- Contact Person Name
- Laia Sans
- Contact Person Email
- web@vallhebron.cat
- Number Of Participants
- 0
- Site Name
- Hospital General La Mancha Centro
- Department Name
- Nephrology
- Principal Investigator Name
- Rebeca García Agudo
- Principal Investigator Email
- rgarciaagudo@aehr.es
- Contact Person Name
- Rebeca García Agudo
- Contact Person Email
- rgarciaagudo@aehr.es
- Number Of Participants
- 0
- Site Name
- Fundacio Puigvert (additional listing may duplicate)
- Department Name
- Servicio de Nefrología
- Principal Investigator Name
- Mónica María Furlano
- Principal Investigator Email
- barcelonacentreprivat@fundacio-puigvert.es
- Contact Person Name
- Mónica María Furlano
- Contact Person Email
- barcelonacentreprivat@fundacio-puigvert.es
- Number Of Participants
- 0
Poland
- Earliest CTIS Part Ii Submission Date
- 18-11-2025
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Stanislaw Niemczyk
- Principal Investigator Email
- badaniakliniczne@wim.mil.pl
- Contact Person Name
- Stanislaw Niemczyk
- Contact Person Email
- badaniakliniczne@wim.mil.pl
- Number Of Participants
- 0
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- Transplantologii i Chorób Wewnętrznych Samodz. Publiczny Zakład OZ
- Principal Investigator Name
- Michal Nowicki
- Principal Investigator Email
- poczta@csk.umed.pl
- Contact Person Name
- Michal Nowicki
- Contact Person Email
- poczta@csk.umed.pl
- Number Of Participants
- 0
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Kliniczny Nefrologii Transplantologii i Chorob Wewnetrznych
- Principal Investigator Name
- Krzysztof Pawlaczyk
- Principal Investigator Email
- szpital@usk.poznan.pl
- Contact Person Name
- Krzysztof Pawlaczyk
- Contact Person Email
- szpital@usk.poznan.pl
- Number Of Participants
- 0
Italy
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 46
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- Nefrologia e Trapianto Rene
- Principal Investigator Name
- Francesca Lugani
- Principal Investigator Email
- nefrologia@gaslini.org
- Contact Person Name
- Francesca Lugani
- Contact Person Email
- nefrologia@gaslini.org
- Number Of Participants
- 0
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Nefrologia, Dialisi e Trapianto
- Principal Investigator Name
- Gaetano La Manna
- Principal Investigator Email
- PEIdirezione.generale@pec.aosp.bo.it
- Contact Person Name
- Gaetano La Manna
- Contact Person Email
- PEIdirezione.generale@pec.aosp.bo.it
- Number Of Participants
- 0
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Nefrologia
- Principal Investigator Name
- Federico Alberici
- Principal Investigator Email
- nefrologia@asst-spedalicivili.it
- Contact Person Name
- Federico Alberici
- Contact Person Email
- nefrologia@asst-spedalicivili.it
- Number Of Participants
- 0
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- Nefrologia
- Principal Investigator Name
- Laura Massella
- Principal Investigator Email
- nefrologia.dialisi@opbg.net
- Contact Person Name
- Laura Massella
- Contact Person Email
- nefrologia.dialisi@opbg.net
- Number Of Participants
- 0
France
- Earliest CTIS Part Ii Submission Date
- 04-09-2025
- Latest Decision Or Authorization Date
- 06-01-2026
- Processing Time Days
- 124
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Department of Nephrology, Transplantation, Dialysis, Apheresis
- Principal Investigator Name
- Claire Rigothier
- Principal Investigator Email
- claire.rigothier@chu-bordeaux.fr
- Contact Person Name
- Claire Rigothier
- Contact Person Email
- claire.rigothier@chu-bordeaux.fr
- Number Of Participants
- 0
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Néphrologie et Transplantation d'organes
- Principal Investigator Name
- Dominique Chauveau
- Principal Investigator Email
- chauveau.d@chu-toulouse.fr
- Contact Person Name
- Dominique Chauveau
- Contact Person Email
- chauveau.d@chu-toulouse.fr
- Number Of Participants
- 0
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Nephrologie - Dialyse Adultes
- Principal Investigator Name
- Bertrand Knebelmann
- Principal Investigator Email
- bertrand.knebelmann@aphp.fr
- Contact Person Name
- Bertrand Knebelmann
- Contact Person Email
- bertrand.knebelmann@aphp.fr
- Number Of Participants
- 0
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Nephrology, Renal Transplant and Hemodialysis
- Principal Investigator Name
- Emilie Cornec - Le Gall
- Principal Investigator Email
- emilie.cornec-legall@chu-brest.fr
- Contact Person Name
- Emilie Cornec - Le Gall
- Contact Person Email
- emilie.cornec-legall@chu-brest.fr
- Number Of Participants
- 0
Portugal
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 88
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Centro Hospitalar Do Medio Tejo E.P.E.
- Department Name
- Nephrology Department
- Principal Investigator Name
- Hernani Goncalves
- Principal Investigator Email
- hernani.goncalves@chmt.min-saude.pt
- Contact Person Name
- Hernani Goncalves
- Contact Person Email
- hernani.goncalves@chmt.min-saude.pt
- Number Of Participants
- 0
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Nephrology Department
- Principal Investigator Name
- Joaquim Calado
- Principal Investigator Email
- joaquim.calado@ulssjose.min-saude.pt
- Contact Person Name
- Joaquim Calado
- Contact Person Email
- joaquim.calado@ulssjose.min-saude.pt
- Number Of Participants
- 0
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Nephrology Department
- Principal Investigator Name
- Ana Marta Gomes
- Principal Investigator Email
- ana.gomes@ulsge.min-saude.pt
- Contact Person Name
- Ana Marta Gomes
- Contact Person Email
- ana.gomes@ulsge.min-saude.pt
- Number Of Participants
- 0
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Nephrology Department
- Principal Investigator Name
- Isabel Tavares
- Principal Investigator Email
- centro.investigacao@chsj.min-saude.pt
- Contact Person Name
- Isabel Tavares
- Contact Person Email
- centro.investigacao@chsj.min-saude.pt
- Number Of Participants
- 0
Sponsor
Primary sponsor
- Full Name
- Bayer AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Third parties
- {"country":"Italy","full_name":"Aptuit (Verona) S.r.l.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Ercules Comunicazioni S.r.l.","duties_or_roles":"Development of Recruitment and Retention materials (R&R)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Labortory Services","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BAY 3401016
- Active Substance
- BAY 3401016
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Investigational Product Name
- Placebo to BAY 3401016
- Modality
- Other
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