Phase
Condition
N/ATreatment
BI 764198
Placebo matching BI 764198
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants ≥18 years of age (≥12 years of age for Treatmentresistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informedconsent/assent (Visit 1)
Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
Weight of ≥40 kg at screening
Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidneydisease (CKD) EPI formula based on serum cystatin C) at screening visit
For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based onserum cystatin C) at the screening visit
For adolescent participants (<18); ≥25 mL/min/1.73 m2 (chronic kidey diseaseunder 25 years (CKiD U25) formula using height and serum cystatin C) at thescreening visit
Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants <18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may beincluded as long as the participant is considered medically stable by theinvestigator and "true" blood pressure can be considered to be ≤160 mmHg (adultparticipants ≥18) or ≤140 mmHg (adolescent participants <18)
Participants should be treated with angiotensin converting enzyme (ACE) inhibitorsor angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8weeks prior to the screening visit (Visit 1), with no plan to change the dose untilthe end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unlessnot tolerated or indicated as per the discretion of the investigator
If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA),endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) orSodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be ona stable dose for at least 8 weeks prior to the screening visit (Visit 1),preferably with no plan to change the dose until the end of the randomiseddouble-blind treatment period (i.e. EoT, Week 20)
Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium,cyclophosphamide) must be on a stable dose for at least 12 weeks prior to thescreening visit (Visit 1) with no plans to change their dose during the trialtreatment period
Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan toincrease the dose during the treatment period.
Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
A history of organ transplantation or planned transplantation during the course ofthe study
Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab,obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
Participants in whom initiation of oral or IV immunosuppression is anticipatedduring the course of the trial
Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5days after the EoT visit
Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior torandomisation visit (Visit 2)
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limitof normal (ULN) at screening visit (Visit 1)
Clinically significant laboratory abnormalities or medical conditions which pose asafety risk for the participant or may interfere with the trial objectives in theinvestigator's opinion (except for renal function tests or deviation of clinicallaboratory values that are related to the podocytopathy in question) at screeningvisit
QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females,or any other clinically relevant ECG findings (at the investigator's discretion) atscreening visit (Visit 1) Further exclusion criteria apply.
Study Design
Connect with a study center
Terapia Renal Domiciliaria
Buenos Aires, 1407
ArgentinaSite Not Available
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, C1425AGC
ArgentinaSite Not Available
Clinica Privada Velez Sarfield
Córdoba, 5000
ArgentinaSite Not Available
CardioAlem Investigaciones
San Isidro, B1642DCD
ArgentinaSite Not Available
Nepean Hospital
Kingswood, New South Wales 2747
AustraliaSite Not Available
John Hunter Hospital
New Lambton Heights, New South Wales 2305
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Brisbane, Queensland 4029
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
AZORG Ziekenhuis
Aalst, 9300
BelgiumSite Not Available
ULB Hopital Erasme
Brussels, 1070
BelgiumSite Not Available
Az Maria Middelares Gent
Ghent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Universidade Federal do Ceara
Fortaleza, 60110-110
BrazilSite Not Available
Universidade Federal do Ceará
Fortaleza, 60110-110
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Fundacao Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002
BrazilActive - Recruiting
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002
BrazilActive - Recruiting
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000
BrazilSite Not Available
Instituto da Crianca e do Adolescente
São Paulo, 05403-901
BrazilSite Not Available
Instituto da Criança e do Adolescente
São Paulo, 05403-901
BrazilSite Not Available
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo 3448439, 04038-002
BrazilSite Not Available
Hospital das Clinicas da FMUSP
São Paulo 3448439, 05403-000
BrazilSite Not Available
CaRe Clinic (Calgary)
Calgary, Alberta T2N 4L7
CanadaSite Not Available
Victoria Hospital (LHSC)
London, Ontario N6A 5W9
CanadaSite Not Available
Maisonneuve-Rosemont Hospital
Monteral, Quebec H1T 2M4
CanadaSite Not Available
Beijing Tsinghua Changgung Hospital
Beijing, 100044
ChinaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaActive - Recruiting
Peking University First Hospital
Beijing 1816670, 100034
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, 610041
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu 1815286, 610041
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, 510080
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing, 210009
ChinaSite Not Available
The First People's Hospital of Nanning
Nanning, 530000
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
ChinaSite Not Available
Shanghai General Hospital
Shanghai, 200080
ChinaSite Not Available
Shanghai General Hospital
Shanghai 1796236, 200080
ChinaSite Not Available
People's Hospital of Sichuan Province
Sichuan, 610031
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, 430060
ChinaSite Not Available
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, 361004
ChinaSite Not Available
Specialty Hospital Medico
Rijeka, 51000
CroatiaSite Not Available
Specijalna Bolnica Medico
Rijeka, 51000
CroatiaSite Not Available
General Hospital Vinkovci
Vinkovci, 32100
CroatiaSite Not Available
Clinical Hospital Sveti Duh
Zagreb, 10000
CroatiaSite Not Available
Solmed Polyclinic
Zagreb, 10000
CroatiaSite Not Available
University Hospital Dubrava
Zagreb, 10000
CroatiaSite Not Available
Clinical Hospital Sveti Duh
Zagreb 3186886, 10000
CroatiaSite Not Available
University Hospital Dubrava
Zagreb 3186886, 10000
CroatiaSite Not Available
Zealand University Hospita; Roskilde
Roskilde, 4000
DenmarkSite Not Available
Tartu University Hospital
Tartu, 50406
EstoniaSite Not Available
CHU Amiens-Picardie
Amiens, 80054
FranceSite Not Available
HOP Pellegrin
Bordeaux, 33076
FranceSite Not Available
Hopital Henri Mondor
Créteil, 94000
FranceSite Not Available
Hôpital Henri Mondor
Créteil, 94000
FranceSite Not Available
Hopital Pasteur
Nice, 06000
FranceSite Not Available
Hôpital Pasteur
Nice, 06000
FranceSite Not Available
Hopital Necker
Paris, 75015
FranceSite Not Available
Hôpital Necker
Paris, 75015
FranceSite Not Available
Vivantes Klinikum im Friedrichshain
Berlin, 10249
GermanySite Not Available
Universitätsklinikum Köln (AöR)
Cologne, 50937
GermanySite Not Available
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
GermanySite Not Available
Medizinische Hochschule Hannover
Hanover, 30625
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität München
München, 81675
GermanySite Not Available
University General Hospital of Heraklion
Heraklion, 71500
GreeceSite Not Available
General University Hospital of Patras
Pátrai, 265 04
GreeceSite Not Available
Aartham Multi Super Speciality Hospital
Ahmedabad, 380015
IndiaSite Not Available
AIIMS Bhubaneshwar
Bhubaneswar, 751019
IndiaSite Not Available
Government Medical College
Kozhikode, 673008
IndiaSite Not Available
Noble Hospital Pvt Ltd
Pune, 411013
IndiaSite Not Available
Galaxy Lifecare Services Pvt. Ltd.
Varanasi, 201010
IndiaSite Not Available
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
ItalySite Not Available
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124
ItalySite Not Available
Policlinico S. Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
A.O.U.Policlinico G.Martino
Messina, 98124
ItalySite Not Available
Asst Santi Paolo E Carlo
Milan, 20142
ItalySite Not Available
Fondazione Salvatore Maugeri
Pavia, 27100
ItalySite Not Available
IRCCS Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo (FG), 71013
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
ItalySite Not Available
Kasugai Municipal Hospital
Aichi, Kasugai, 486-8510
JapanSite Not Available
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi, Nagoya, 466-8650
JapanActive - Recruiting
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555
JapanSite Not Available
Kobe University Hospital
Hyogo, Kobe, 650-0017
JapanSite Not Available
The Jikei University Hospital
Tokyo, Minato-ku, 105-8471
JapanSite Not Available
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666
JapanSite Not Available
Hospital Selayang
Batu Caves, 68100
MalaysiaSite Not Available
Hospital Sultan Idris Shah Serdang
Kajang, 43000
MalaysiaSite Not Available
Sunway Medical Centre
Selangor Darul Ehsan, 47500
MalaysiaSite Not Available
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259
MexicoSite Not Available
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
MexicoSite Not Available
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
MexicoSite Not Available
Soltmed Smo
Mexico City, 03650
MexicoSite Not Available
Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal
Monterrey, 64060
MexicoSite Not Available
Instituto Nacional de Cardiologia Ignacio Chavez
Tlalpan, 14080
MexicoSite Not Available
Amsterdam UMC Locatie AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
Pacific Clinical Research Network - Auckland
Auckland, 622
New ZealandSite Not Available
Waikato Hospital
Hamilton, 3204
New ZealandSite Not Available
Akershus Universitetssykehus HF
Lørenskog, 1478
NorwaySite Not Available
Oslo Universitetssykehus HF, Ulleval sykehus
Oslo, 0450
NorwaySite Not Available
Oslo Universitetssykehus HF, Ullevål sykehus
Oslo, 0450
NorwaySite Not Available
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, N-4011
NorwaySite Not Available
Universitetssykehuset Nord-Norge, Tromso
Tromsø, 9019
NorwaySite Not Available
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, 9019
NorwaySite Not Available
Central Clinical Hospital of the Medical University of Lodz
Lodz, 92-213
PolandSite Not Available
Central Teaching Hospital of the Medical University of Lodz
Lodz 3093133, 92-213
PolandSite Not Available
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-355
PolandSite Not Available
Pomorski Uniwersytet Medyczny w Szczecinie, Samodzielny Publiczny Szpital Kliniczny nr 2
Szczecin, 70-111
PolandSite Not Available
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Szczecin, 70-111
PolandSite Not Available
Central Clinical Hospital of the Ministry of National Defence - Military Institute of Medicine
Warsaw, 04-141
PolandSite Not Available
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
Warsaw, 02-091
PolandSite Not Available
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
Warsaw 756135, 02-091
PolandSite Not Available
Unidade Local de Saúde de Almada-Seixal E.P.E.
Almada, 2805-267
PortugalSite Not Available
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada 2271961, 2805-267
PortugalSite Not Available
ULS Braga
Braga, 4710-243
PortugalSite Not Available
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
PortugalSite Not Available
Unidade Local de Saúde Lisboa Occidental, E.P.E
Lisbon, 2790-134
PortugalSite Not Available
ULS de São José
Lisbon 2267057, 1069-166
PortugalSite Not Available
ULS de Loures-Odivelas, E.P.E
Loures, 2674-514
PortugalSite Not Available
Institutul Clinic Fundeni
Bucharest, 022328
RomaniaSite Not Available
Fundeni Clinical Institute
Bucharest 683506, 2
RomaniaSite Not Available
County Emergency Hospital "Pius Brinzeu" Timisoara
Timișoara, 300723
RomaniaSite Not Available
Singapore General Hospital
Singapore, 169608
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 975 17
SlovakiaSite Not Available
University Hospital and Comenius University in Bratislava, Derer´s Hospital
Bratislava, 833 05
SlovakiaSite Not Available
FMC Dialysis Services Kosice
Košice, 40190
SlovakiaSite Not Available
Univerzitna nemocnica L. Pasteura Kosice
Košice, 041 90
SlovakiaSite Not Available
Univerzitna nemocnica L. Pasteura Kosice
Košice 724443, 041 90
SlovakiaSite Not Available
Univ. Hospital Martin
Martin, 036 01
SlovakiaSite Not Available
Kyung Hee University Hospital at Gangdong
Seoul, 05278
South KoreaSite Not Available
Ajou University Hospital
Suwon, 16499
South KoreaSite Not Available
Hospital Universitari Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
SpainSite Not Available
Hospital Universitario Virgen de las Nieves
Granada, 18014
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
SpainSite Not Available
Danderyds Sjukhus
Danderyd, 182 88
SwedenSite Not Available
Universitetssjukhuset, Linköping
Linköping, 581 85
SwedenSite Not Available
Uppsala University Hospital
Uppsala, 751 85
SwedenSite Not Available
Klinik Hirslanden
Zurich, 8032
SwitzerlandSite Not Available
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 40447
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
China Medical University Hospital
Taichung 1668399, 40447
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100225
TaiwanActive - Recruiting
Adana City Hospital
Adana, 01220
Turkey (Türkiye)Site Not Available
Ankara Etlik City Hospital
Ankara, 06200
Turkey (Türkiye)Site Not Available
Bursa Uludag University
Bursa, 16110
Turkey (Türkiye)Site Not Available
Istanbul Capa University
Istanbul, 34093
Turkey (Türkiye)Site Not Available
İstanbul Çapa University
Istanbul, 34093
Turkey (Türkiye)Site Not Available
Erciyes University
Melikgazi/Kayseri, 38039
Turkey (Türkiye)Site Not Available
Kocaeli University Faculty of Medicine Hospital
İzmit, 41000
Turkey (Türkiye)Site Not Available
Bradford Institute for Health Research
Bradford, BD9 6RJ
United KingdomActive - Recruiting
King's College Hospital
London, SE5 9RS
United KingdomActive - Recruiting
The Royal London Hospital
London, E1 1BB
United KingdomActive - Recruiting
The Royal London Hospital
London 2643743, E1 1BB
United KingdomSite Not Available
Salford Royal
Salford, M6 8HD
United KingdomSite Not Available
Nephrology Consultants, LLC
Huntsville, Alabama 35805
United StatesSite Not Available
Kidney Disease Medical Group
Glendale, California 91206
United StatesSite Not Available
Amicis Research Center - Balboa
Granada Hills, California 91344
United StatesSite Not Available
Academic Medical Research Institute - Glendale
Los Angeles, California 90022
United StatesSite Not Available
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
Academic Medical Research Institute - Glendale
Los Angeles 5368361, California 5332921 90022
United StatesSite Not Available
Colorado Kidney Care
Denver, Colorado 80220
United StatesSite Not Available
Colorado Kidney Center
Denver, Colorado 80220
United StatesSite Not Available
Florida Kidney Physicians - Boca Raton
Boca Raton, Florida 33487
United StatesSite Not Available
Florida Kidney Physicians, LLC - Fort Lauderdale
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Total Research Group, LLC
Miami, Florida 33126
United StatesActive - Recruiting
CTR Oakwater, LLC
Orlando, Florida 32806
United StatesSite Not Available
Panoramic Health
Riverview, Florida 33578
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Endeavor Health
Evanston, Illinois 60201
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
St. Clair Nephrology Research, LLC - Shelby Township
Shelby, Michigan 48315
United StatesSite Not Available
New York Nephrology and Dialysis Access Surgery, PC
Clifton Park, New York 12065
United StatesSite Not Available
NYU Langone Nephrology Associates-Mineola
Mineola, New York 11501
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
Southeast Renal Research Institute
Chattanooga, Tennessee 37404
United StatesSite Not Available
Nephrotex Research Group
Dallas, Texas 75231
United StatesSite Not Available
Provecta Researh Network
Houston, Texas 77027
United StatesSite Not Available
West Virginia University Medicine
Morgantown, West Virginia 26506
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.