Clinical trial • Nephrology|Rare Disease

[4-(6-AMINOPYRIDAZIN-3-YL)PIPERIDIN-1-YL][5-(4-FLUOROPHENOXY)-4-METHOXYPYRIDIN-2-YL]METHANONE for Focal segmental glomerulosclerosis|Genetic focal segmental glomerulosclerosis (TRPC6 gain-of-function mutation)

Clinical trial of [4-(6-AMINOPYRIDAZIN-3-YL)PIPERIDIN-1-YL][5-(4-FLUOROPHENOXY)-4-METHOXYPYRIDIN-2-YL]METHANONE for Focal segmental glomerulosclerosis|Gen…

Overview

Trial Therapeutic Area
Nephrology|Rare Disease
Trial Disease
Focal segmental glomerulosclerosis|Genetic focal segmental glomerulosclerosis (TRPC6 gain-of-function mutation)
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
13-11-2025
First CTIS Authorization Date
17-03-2026

Trial design

Randomised, placebo matching bi 764198 (oral, matching film-coated tablet). dose and schedule not specified in the submitted product metadata.-controlled trial in Belgium, Croatia, Denmark and others.

Randomised
Yes
Comparator
Placebo matching BI 764198 (oral, matching film-coated tablet). Dose and schedule not specified in the submitted product metadata.
Target Sample Size
182
Trial Duration For Participant
728

Eligibility

Recruits 182 paediatric patients.

Vulnerable Population
The trial includes adolescent participants (≥12 to <18 years). Consent/assent handling: informed consent is obtained from adult participants; for minors parental/legal guardian consent and parental information forms are provided and assent forms are available for adolescents (documents labelled l1_icf-parental and l1_icf-assent appear in the submission). Country- and language-specific consent, parental and assent documents are provided (multiple translated versions listed in the submission).

Inclusion criteria

  • {"criterion_text":"- 1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)\n- 2. Weight of ≥40 kg at the screening visit (Visit 1)\n- 3. Body Mass Index (BMI) of ≤40 kg/m2 at the screening visit (Visit 1)\n- 4. Participants with a diagnosis prior to the screening visit (Visit 1) of either: - biopsy-confirmed pFSGS (based on Investigator’s judgement) OR - genetic FSGS resulting from a gain-of-function gene mutation in the TRPC6 gene (based on historical genetic test)\n- 5. UPCR ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1)\n- 6. Estimated glomerular filtration rate (eGFR) - For adult participants (≥18): ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit (Visit 1) - For adolescent participants (12 to <18 years); ≥25 mL/min/1.73 m2 based on CKiD U25 formula using height and serum cystatin C at the screening visit (Visit 1)\n- 7. Further inclusion criteria apply."}

Exclusion criteria

  • {"criterion_text":"- 1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)\n- 2. Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator’s judgement)\n- 3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator’s judgement)\n- 4. A history of organ transplantation or planned organ transplantation during the course of the trial\n- 5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1)\n- 6. Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104","definition_or_measurement_approach":"Mean relative change from baseline to Week 104 in 24-hour urinary protein-to-creatinine ratio (UPCR), measured in mg/g (central laboratory measurement)."}

Secondary endpoints

  • {"endpoint_text":"- Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104\n- Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104\n- Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint)\n- Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104\n- Change from baseline across disease-specific COA NS-SIM-PRO at Week 104\n- Change from baseline across Clinical Outcome Assessment (COA) KDQOL-36 at Week 104","definition_or_measurement_approach":"Endpoints include absolute change in eGFR based on serum cystatin C (eGFRcys, measured in mL/min/1.73m2) from baseline to Week 104; treatment response defined by 24-hour UPCR thresholds at Week 104; combined endpoint requiring UPCR <1000 mg/g and eGFRcys ≥85% vs baseline with no treatment failure; complete remission defined as 24-hr UPCR <300 mg/g at Week 104; patient-reported outcome changes on NS-SIM-PRO and KDQOL-36 instruments from baseline to Week 104."}

Other endpoints

  • {"endpoint_text":"- The assessment of clinical endpoints related to kidney disease progression, e.g. sustained eGFRcys decline or end-stage kidney disease\n- The assessment of need for rescue therapy or intensification of co-medication due to treatment failure\n- The assessment of treatment effects on participant quality of life by assessment of pertinent patient reported outcome measures including KDQOL-36 and the NS-SIMPRO aimed at assessing the burden of oedema in nephrotic syndrome","definition_or_measurement_approach":"Clinical progression endpoints (sustained eGFRcys decline or ESKD); need for rescue therapy or intensification of concomitant medication due to treatment failure; changes in QoL measured by KDQOL-36 and disease-specific COA NS-SIM-PRO."}

Recruitment

Planned Sample Size
182
Recruitment Window Months
51
Consent Approach
Informed consent is obtained from adult participants. For participants aged 12 to <18 years, parental/legal guardian consent is required and assent from the adolescent is obtained (assent and parental consent documents are included in country-specific submissions). Multiple country/language-specific informed consent, parental and assent documents are provided across the submission (e.g. English, German, French, Spanish, Italian, Dutch, Polish, Portuguese, Romanian, Slovak, Swedish, Norwegian, Croatian, Danish, Greek among others).

Geography

Total Number Of Sites
73
Total Number Of Participants
105

Belgium

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
12
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Azorg
Department Name
Nephrology department
Principal Investigator Name
Bruno Van Vlem
Principal Investigator Email
bruno.van.vlem@azorg.be
Contact Person Name
Bruno Van Vlem
Contact Person Email
bruno.van.vlem@azorg.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Nephrology-dialysis Department - Route 467
Principal Investigator Name
Antoine BOUQUEGNEAU
Principal Investigator Email
antoine.bouquegneau@chuliege.be
Contact Person Name
Antoine BOUQUEGNEAU
Site Name
UZ Leuven
Department Name
Nephrology secretariat - Green route, door 7 Level + 2
Principal Investigator Name
Bjorn Meijers
Principal Investigator Email
bjorn.meijers@uzleuven.be
Contact Person Name
Bjorn Meijers
Contact Person Email
bjorn.meijers@uzleuven.be

Croatia

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
30
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
University Hospital Sveti Duh
Department Name
Department of Nephrology
Principal Investigator Name
Ivana Mikačić
Principal Investigator Email
mikacicivana@yahoo.com
Contact Person Name
Ivana Mikačić
Contact Person Email
mikacicivana@yahoo.com
Site Name
Poliklinika BONIFARM
Department Name
Bonifarm Polyclinic
Principal Investigator Name
Ivana Vukovic Brinar
Principal Investigator Email
ivemedex@yahoo.com
Contact Person Name
Ivana Vukovic Brinar
Contact Person Email
ivemedex@yahoo.com

Denmark

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
25
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Region Sjaelland
Department Name
Dept. of Medicine, Clinical Research Unit
Principal Investigator Name
Rikke Borg
Principal Investigator Email
rbor@regionsjaelland.dk
Contact Person Name
Rikke Borg
Contact Person Email
rbor@regionsjaelland.dk
Site Name
Rigshospitalet
Department Name
Nefrologisk Klinik P og Endokrinologisk Klinik PE Afsnit 2131, Opgang 2, 13.sal
Principal Investigator Name
Nicholas Carlson
Principal Investigator Email
Nicholas.carlson.01@regionh.dk
Contact Person Name
Nicholas Carlson
Contact Person Email
Nicholas.carlson.01@regionh.dk

Germany

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
22
Number Of Sites
7
Number Of Participants
11

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Abteilung Nephrologie
Principal Investigator Name
Jule Pinter
Principal Investigator Email
Pinter_J@ukw.de
Contact Person Name
Jule Pinter
Contact Person Email
Pinter_J@ukw.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Klinik II für Innere Medizin: Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Principal Investigator Name
Paul Brinkkötter
Principal Investigator Email
paul.brinkkoetter@uk-koeln.de
Contact Person Name
Paul Brinkkötter
Contact Person Email
paul.brinkkoetter@uk-koeln.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Kinder- und Jugendmedizin, ped.UCiT-Studiencentrum
Principal Investigator Name
Jun Oh
Principal Investigator Email
j.oh@uke.de
Contact Person Name
Jun Oh
Contact Person Email
j.oh@uke.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Nephrologie - Nierenzentrum Heidelberg
Principal Investigator Name
Claudia Sommerer
Principal Investigator Email
claudia.sommerer@med.uni-heidelberg.de
Contact Person Name
Claudia Sommerer
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Endokrinologie und Nephrologie
Principal Investigator Name
Jan Kowald
Principal Investigator Email
Jan.Kowald@medizin.uni-leipzig.de
Contact Person Name
Jan Kowald
Site Name
Medizinische Hochschule Hannover
Department Name
Studienzentrum für Nieren- und Hochdruckerkrankungen
Principal Investigator Name
Jessica Kaufeld
Principal Investigator Email
kaufeld.jessica@mh-hannover.de
Contact Person Name
Jessica Kaufeld
Contact Person Email
kaufeld.jessica@mh-hannover.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Med. Klinik und Poliklinik / Schwerpunkt Abteilung Nephrologie
Principal Investigator Name
Julia Weinmann Menke
Principal Investigator Email
julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann Menke

Greece

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
104
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
General University Hospital Of Patras
Department Name
Department of Nephrology and Kidney Transplantation
Principal Investigator Name
Evangelos Papachristou
Principal Investigator Email
epapadoct@hotmail.com
Contact Person Name
Evangelos Papachristou
Contact Person Email
epapadoct@hotmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Nephrology clinic
Principal Investigator Name
Konstantinos Stylianou
Principal Investigator Email
kstylianu@gmail.com
Contact Person Name
Konstantinos Stylianou
Contact Person Email
kstylianu@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
31
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
UO di Nefrologia e Dialisi
Principal Investigator Name
Marco Guarneri
Principal Investigator Email
marco.guarneri@policlinico.pa.it
Contact Person Name
Marco Guarneri
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Struttura Complessa Nefrologia e Dialisi
Principal Investigator Name
Andrea Ambrosini
Principal Investigator Email
andrea.ambrosini@asst-settelaghi.it
Contact Person Name
Andrea Ambrosini
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UOC Nefrologia, Dialisi e Trapianto
Principal Investigator Name
Loreto Gesualdo
Principal Investigator Email
loretogesualdo.trialid@gmail.com
Contact Person Name
Loreto Gesualdo
Site Name
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
Department Name
Unità di Nefrologia, Dialisi e Trapianto
Principal Investigator Name
Ciro Esposito
Principal Investigator Email
ciro.esposito@icsmaugeri.it
Contact Person Name
Ciro Esposito
Contact Person Email
ciro.esposito@icsmaugeri.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Struttura Complessa Nefrologia e Dialisi
Principal Investigator Name
Mario Cozzolino
Principal Investigator Email
mario.cozzolino@asst-santipaolocarlo.it
Contact Person Name
Mario Cozzolino
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
gaetano.lamanna@unibo.it
Contact Person Name
Gaetano La Manna
Contact Person Email
gaetano.lamanna@unibo.it

Portugal

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
45
Number Of Sites
10
Number Of Participants
7

Sites

Site Name
Unidade Local De Saude Da Arrabida E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Karina Soto
Principal Investigator Email
karina.soto@ulsa.min-saude.pt
Contact Person Name
Karina Soto
Contact Person Email
karina.soto@ulsa.min-saude.pt
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Fernando Teixeira e Costa
Principal Investigator Email
teixeiraecosta@gmail.com
Contact Person Name
Fernando Teixeira e Costa
Contact Person Email
teixeiraecosta@gmail.com
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Serviço de Nefrologia
Principal Investigator Name
Ana Costa
Principal Investigator Email
Ana.Costa3@ulslod.min-saude.pt
Contact Person Name
Ana Costa
Contact Person Email
Ana.Costa3@ulslod.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Diogo Francisco
Principal Investigator Email
diogo.francisco@ulssjose.min-saude.pt
Contact Person Name
Diogo Francisco
Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Fernando Domingos
Principal Investigator Email
fernando.m.domingos@ulsasi.min-saude.pt
Contact Person Name
Fernando Domingos
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Pedro Castro
Principal Investigator Email
pedro.aam.castro@gmail.com
Contact Person Name
Pedro Castro
Contact Person Email
pedro.aam.castro@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Ivo Laranjinha
Principal Investigator Email
ilaranjinha@ulslo.min-saude.pt
Contact Person Name
Ivo Laranjinha
Contact Person Email
ilaranjinha@ulslo.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Servico de Nefrologia
Principal Investigator Name
Joana Gameiro
Principal Investigator Email
joana.estrelagameiro@gmail.com
Contact Person Name
Joana Gameiro
Contact Person Email
joana.estrelagameiro@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Nefrologia
Principal Investigator Name
Sofia Marques
Principal Investigator Email
sofia.marques@ulsb.min-saude.pt
Contact Person Name
Sofia Marques
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Serviço de Nefrologia
Principal Investigator Name
Sofia Correia
Contact Person Name
Sofia Correia

Romania

Earliest CTIS Part Ii Submission Date
19-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
11
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Department of Nephrology, Transplantology and Clinical Immunology
Principal Investigator Name
Gener Ismail
Principal Investigator Email
gener732000@yahoo.com
Contact Person Name
Gener Ismail
Contact Person Email
gener732000@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Clinical Department of Nephrology
Principal Investigator Name
Ina Maria Kacso
Principal Investigator Email
inakacso@yahoo.com
Contact Person Name
Ina Maria Kacso
Contact Person Email
inakacso@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
28
Number Of Sites
11
Number Of Participants
11

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Nefrología
Principal Investigator Name
Eduardo Gutiérrez
Principal Investigator Email
eduardogutmat90@gmail.com
Contact Person Name
Eduardo Gutiérrez
Contact Person Email
eduardogutmat90@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Servicio de Nefrología
Principal Investigator Name
Raquel Lopez
Principal Investigator Email
rlopezh@senefro.org
Contact Person Name
Raquel Lopez
Contact Person Email
rlopezh@senefro.org
Site Name
Hospital Universitario Torrecardenas
Department Name
Servicio de Nefrología
Principal Investigator Name
Francisco Gonzalez Martinez
Principal Investigator Email
fcurro@yahoo.com
Contact Person Name
Francisco Gonzalez Martinez
Contact Person Email
fcurro@yahoo.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Nefrología
Principal Investigator Name
Luis Quintana Porras
Principal Investigator Email
lfquinta@clinic.cat
Contact Person Name
Luis Quintana Porras
Contact Person Email
lfquinta@clinic.cat
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Servicio de Nefrología
Principal Investigator Name
Alvaro Madrid Aris
Principal Investigator Email
alvaro.madrid@sjd.es
Contact Person Name
Alvaro Madrid Aris
Contact Person Email
alvaro.madrid@sjd.es
Site Name
Hospital Clinico San Carlos
Department Name
Servicio de Nefrología
Principal Investigator Name
Antolina Rodriguez Moreno
Principal Investigator Email
antolina.romo@hotmail.com
Contact Person Name
Antolina Rodriguez Moreno
Contact Person Email
antolina.romo@hotmail.com
Site Name
Hospital Del Mar
Department Name
Servicio de Nefrología
Principal Investigator Name
Eva Rodríguez
Principal Investigator Email
erodriguezg@hmar.cat
Contact Person Name
Eva Rodríguez
Contact Person Email
erodriguezg@hmar.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Nefrología
Principal Investigator Name
María José Soler Romeo
Principal Investigator Email
mariajose.soler@vallhebron.cat
Contact Person Name
María José Soler Romeo
Contact Person Email
mariajose.soler@vallhebron.cat
Site Name
Hospital Universitario Torrecardenas (duplicate entry not assumed)
Department Name
Servicio de Nefrología
Principal Investigator Name
Francisco Gonzalez Martinez
Principal Investigator Email
fcurro@yahoo.com
Contact Person Name
Francisco Gonzalez Martinez
Contact Person Email
fcurro@yahoo.com
Site Name
Hospital Universitario Virgen De Las Nieves (duplicate entry not assumed)
Department Name
Servicio de Nefrología
Principal Investigator Name
Raquel Lopez
Principal Investigator Email
rlopezh@senefro.org
Contact Person Name
Raquel Lopez
Contact Person Email
rlopezh@senefro.org
Site Name
Hospital Universitari 12 De Octubre (duplicate entry not assumed)
Department Name
Servicio de Nefrología
Principal Investigator Name
Eduardo Gutiérrez
Principal Investigator Email
eduardogutmat90@gmail.com
Contact Person Name
Eduardo Gutiérrez
Contact Person Email
eduardogutmat90@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
39
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Danderyds Sjukhus AB
Department Name
Department of Nephrology
Principal Investigator Name
Sigrid Lundberg
Principal Investigator Email
sigrid.lundberg@ki.se
Contact Person Name
Sigrid Lundberg
Contact Person Email
sigrid.lundberg@ki.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Nephrology Department
Principal Investigator Name
Sophie Ohlsson
Principal Investigator Email
sophie.ohlsson@med.lu.se
Contact Person Name
Sophie Ohlsson
Contact Person Email
sophie.ohlsson@med.lu.se
Site Name
Karolinska University Hospital
Department Name
Huddinge, K88
Principal Investigator Name
Peter Barany
Principal Investigator Email
peter.barany@regionstockholm.se
Contact Person Name
Peter Barany
Site Name
Region Oestergoetland
Department Name
Njurmedicinska kliniken, Mottagning
Principal Investigator Name
Annette Bruchfeld
Principal Investigator Email
annette.bruchfeld@liu.se
Contact Person Name
Annette Bruchfeld
Contact Person Email
annette.bruchfeld@liu.se
Site Name
Uppsala University Hospital
Department Name
Department of Medical Sciences, Renal Medicine
Principal Investigator Name
Maria Svensson
Principal Investigator Email
maria.k.svensson@ucr.uu.se
Contact Person Name
Maria Svensson
Contact Person Email
maria.k.svensson@ucr.uu.se

Netherlands

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
14
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Nephrology
Principal Investigator Name
Rutger Maas
Principal Investigator Email
rutger.maas@radboudumc.nl
Contact Person Name
Rutger Maas
Contact Person Email
rutger.maas@radboudumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Nephrology
Principal Investigator Name
Mark Eijgelsheim
Principal Investigator Email
m.eijgelsheim@umcg.nl
Contact Person Name
Mark Eijgelsheim
Contact Person Email
m.eijgelsheim@umcg.nl
Site Name
Amsterdam UMC Stichting
Department Name
Department of Internal Medicine
Principal Investigator Name
Liffert Vogt
Principal Investigator Email
l.vogt@amsterdamumc.nl
Contact Person Name
Liffert Vogt
Contact Person Email
l.vogt@amsterdamumc.nl

Norway

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
24
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Helse Stavanger HF
Department Name
Nyreseksjon
Principal Investigator Name
Lasse Gunnar Gøransson
Principal Investigator Email
lasse.gunnar.goransson@sus.no
Contact Person Name
Lasse Gunnar Gøransson
Contact Person Email
lasse.gunnar.goransson@sus.no
Site Name
Oslo Universitetssykehus HF
Department Name
Nyremedisinsk avdeling, , 4th floor
Principal Investigator Name
Bård Waldum Grevbo
Principal Investigator Email
b.e.waldum-grevbo@medisin.uio.no
Contact Person Name
Bård Waldum Grevbo
Site Name
Akershus University Hospital
Department Name
Nyremedisinsk avdeling
Principal Investigator Name
Bartlomiej Jozef Witczak
Principal Investigator Email
Bartlomiej.Jozef.Witczak@ahus.no
Contact Person Name
Bartlomiej Jozef Witczak
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Section of Nephrology
Principal Investigator Name
Jon Viljar Norvik
Principal Investigator Email
jon.viljar.porserud.norvik@unn.no
Contact Person Name
Jon Viljar Norvik

Poland

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
29
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnetrznych
Principal Investigator Name
Michał Nowicki
Principal Investigator Email
michal.nowicki@umed.lodz.pl
Contact Person Name
Michał Nowicki
Contact Person Email
michal.nowicki@umed.lodz.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Katedra i Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Principal Investigator Name
Krzysztof Pawlaczyk
Principal Investigator Email
kpawlac@ump.edu.pl
Contact Person Name
Krzysztof Pawlaczyk
Contact Person Email
kpawlac@ump.edu.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Chorób Wewnętrznych, Nefrologii i Dializoterapii
Principal Investigator Name
Karolina Konieczniak
Principal Investigator Email
kkonieczniak@wim.mil.pl
Contact Person Name
Karolina Konieczniak
Contact Person Email
kkonieczniak@wim.mil.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Nefrologii, Trasnplantologii i Chorób Wewnetrznych
Principal Investigator Name
Kazimierz Ciechanowski
Principal Investigator Email
kazimierz.ciechanowski@pum.edu.pl
Contact Person Name
Kazimierz Ciechanowski

Slovakia

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
27
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Univerzitna Nemocnica Martin
Department Name
Univerzitna Nemocnica Martin
Principal Investigator Name
Matej Vnucak
Principal Investigator Email
vnucak.matej@gmail.com
Contact Person Name
Matej Vnucak
Contact Person Email
vnucak.matej@gmail.com
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Luois Pasteur University Hosp Kosice Transplatation department
Principal Investigator Name
Tatiana Baltesova
Principal Investigator Email
tatiana.baltesova@unlp.sk
Contact Person Name
Tatiana Baltesova
Contact Person Email
tatiana.baltesova@unlp.sk

France

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
126
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service Néphrologie-Dialyse-Aphérèse
Principal Investigator Name
Olivier Moranne
Principal Investigator Email
olivier.moranne@chu-nimes.fr
Contact Person Name
Olivier Moranne
Contact Person Email
olivier.moranne@chu-nimes.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service de Néphrologie, Hémodialyse et Transplantation Rénale
Principal Investigator Name
Emilie Cornec Le Gall
Principal Investigator Email
emilie.cornec-legall@chu-brest.fr
Contact Person Name
Emilie Cornec Le Gall
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service de Néphrologie, Médecine interne, Dialyse, Transplantation
Principal Investigator Name
Gabriel Choukroun
Principal Investigator Email
choukroun.gabriel@chu-amiens.fr
Contact Person Name
Gabriel Choukroun
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Néphrologie
Principal Investigator Name
Barbara Seitz-Polski
Principal Investigator Email
seitz-polski.b@chu-nice.fr
Contact Person Name
Barbara Seitz-Polski
Contact Person Email
seitz-polski.b@chu-nice.fr
Site Name
Hospices Civils De Lyon
Department Name
Service de néphrologie et d’explorations fonctionnelles rénales
Principal Investigator Name
Sandrine Lemoine
Principal Investigator Email
sandrine.lemoine01@chu-lyon.fr
Contact Person Name
Sandrine Lemoine
Contact Person Email
sandrine.lemoine01@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Service de Néphrologie et Transplantation
Principal Investigator Name
Vincent Audard
Principal Investigator Email
vincent.audard@aphp.fr
Contact Person Name
Vincent Audard
Contact Person Email
vincent.audard@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
Service de néphrologie 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
Site Name
CHRU De Nancy
Department Name
Service néphrologie
Principal Investigator Name
Adrien Flahault
Principal Investigator Email
A.FLAHAULT@chru-nancy.fr
Contact Person Name
Adrien Flahault
Contact Person Email
A.FLAHAULT@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service Néphrologie, Transplantation, Dialyse et Aphérèses
Principal Investigator Name
Claire Rigothier
Principal Investigator Email
claire.rigothier@chu-bordeaux.fr
Contact Person Name
Claire Rigothier
Site Name
Centre Hospitalier Universitaire De Nimes (duplicate entry not assumed)
Department Name
Service Néphrologie-Dialyse-Aphérèse
Principal Investigator Name
Olivier Moranne
Principal Investigator Email
olivier.moranne@chu-nimes.fr
Contact Person Name
Olivier Moranne
Contact Person Email
olivier.moranne@chu-nimes.fr

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
Start-up & Contract negotiation (and other duties as indicated by codes 1 and 12 in sponsorDuties)

Third parties

  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12,15; 15: Start-up & Contract negotiation","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 764198
Active Substance
[4-(6-AMINOPYRIDAZIN-3-YL)PIPERIDIN-1-YL][5-(4-FLUOROPHENOXY)-4-METHOXYPYRIDIN-2-YL]METHANONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Investigational Product Name
Placebo matching BI 764198
Modality
Other

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