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NCT07355296PHASE2Recruiting

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Boehringer Ingelheim

Start Date

3/23/2026

Completion Date

2/17/2028

Summary

This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/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 kidney disease (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 on serum cystatin C) at the screening visit * For adolescent participants (\<18); ≥25 mL/min/1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening 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 be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \<18) * Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not 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) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a 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 randomised double-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 the screening visit (Visit 1) with no plans to change their dose during the trial treatment period * Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period. Further inclusion criteria apply. Exclusion Criteria: * A history of organ transplantation or planned transplantation during the course of the 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 anticipated during 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 5 days 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 to randomisation visit (Visit 2) * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>3X the upper limit of normal (ULN) at screening visit (Visit 1) * Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit * 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) at screening visit (Visit 1) Further exclusion criteria apply.

Interventions

DRUG

BI 764198

DRUG

Placebo matching BI 764198

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Conditions

Proteinuric Kidney Diseases

Locations

Nephrology Consultants, LLC

Huntsville, Alabama 35805

United States

Kidney Disease Medical Group

Glendale, California 91206

United States

Amicis Research Center - Balboa

Granada Hills, California 91344

United States

Academic Medical Research Institute - Glendale

Los Angeles, California 90022

United States

University of California Los Angeles

Los Angeles, California 90095

United States

Colorado Kidney Care

Denver, Colorado 80220

United States

Florida Kidney Physicians - Boca Raton

Boca Raton, Florida 33487

United States

Florida Kidney Physicians, LLC - Fort Lauderdale

Fort Lauderdale, Florida 33316

United States

Total Research Group, LLC

Miami, Florida 33126

United States

CTR Oakwater, LLC

Orlando, Florida 32806

United States

Florida Kidney Physicians - Riverview/Brandon

Riverview, Florida 33578

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Endeavor Health

Evanston, Illinois 60201

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

St. Clair Nephrology Research, LLC - Shelby Township

Shelby, Michigan 48315

United States

New York Nephrology and Dialysis Access Surgery, PC

Clifton Park, New York 12065

United States

NYU Langone Nephrology Associates-Mineola

Mineola, New York 11501

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania 18017

United States

Southeast Renal Research Institute

Chattanooga, Tennessee 37404

United States

Nephrotex Research Group

Dallas, Texas 75231

United States

Provecta Researh Network

Houston, Texas 77027

United States

West Virginia University Medicine

Morgantown, West Virginia 26506

United States

Terapia Renal Domiciliaria

Buenos Aires, 1407

Argentina

Centro Medico Dra Laura Maffei

Ciudad Autonoma Buenos Aires, C1425AGC

Argentina

Clinica Privada Velez Sarfield

Córdoba, 5000

Argentina

CardioAlem Investigaciones

San Isidro, B1642DCD

Argentina

Nepean Hospital

Kingswood, New South Wales 2747

Australia

John Hunter Hospital

New Lambton Heights, New South Wales 2305

Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland 4029

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

AZORG Ziekenhuis

Aalst, 9300

Belgium

Hopital Erasme

Brussels, 1070

Belgium

Az Maria Middelares Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Universidade Federal do Ceara

Fortaleza, 60110-110

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

Fundacao Oswaldo Ramos (Hospital do Rim)

São Paulo, 04038-002

Brazil

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05403-000

Brazil

Instituto da Crianca e do Adolescente

São Paulo, 05403-901

Brazil

CaRe Clinic (Calgary)

Calgary, Alberta T2N 4L7

Canada

Victoria Hospital (LHSC)

London, Ontario N6A 5W9

Canada

Maisonneuve-Rosemont Hospital

Monteral, Quebec H1T 2M4

Canada

Peking University First Hospital

Beijing, 100034

China

Beijing Tsinghua Changgung Hospital

Beijing, 102218

China

West China Hospital, Sichuan University

Chengdu, 610041

China

Guangdong Provincial People's Hospital

Guangzhou, 510080

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330006

China

Zhongda Hospital Southeast University

Nanjing, 210009

China

The First People's Hospital of Nanning

Nanning, 530000

China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025

China

Shanghai General Hospital

Shanghai, 200080

China

People's Hospital of Sichuan Province

Sichuan, 610031

China

Renmin Hospital of Wuhan University

Wuhan, 430060

China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, 361004

China

Specijalna Bolnica Medico

Rijeka, 51000

Croatia

General Hospital Vinkovci

Vinkovci, 32100

Croatia

Clinical Hospital Sveti Duh

Zagreb, 10000

Croatia

Solmed Polyclinic

Zagreb, 10000

Croatia

University Hospital Dubrava

Zagreb, 10000

Croatia

Zealand University Hospita; Roskilde

Roskilde, 4000

Denmark

Tartu University Hospital

Tartu, 50406

Estonia

CHU Amiens-Picardie

Amiens, 80054

France

HOP Pellegrin

Bordeaux, 33076

France

Hopital Henri Mondor

Créteil, 94000

France

Hopital Pasteur

Nice, 06000

France

Hopital Necker

Paris, 75015

France

Vivantes Klinikum im Friedrichshain

Berlin, 10249

Germany

Universitätsklinikum Köln (AöR)

Cologne, 50937

Germany

Universitätsklinikum Hamburg, Eppendorf

Hamburg, 20246

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131

Germany

Klinikum rechts der Isar der Technischen Universität München

München, 81675

Germany

University General Hospital of Heraklion

Heraklion, 71500

Greece

General University Hospital of Patras

Pátrai, 265 04

Greece

Aartham Multi Super Speciality Hospital

Ahmedabad, 380015

India

AIIMS Bhubaneshwar

Bhubaneswar, 751019

India

Osmania Medical College & Hospital

Hyderabad, 500012

India

Nizam's Institute of Medical Sciences

Hyderabad, 500082

India

Government Medical College

Kozhikode, 673008

India

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, 226014

India

JSS Medical College

Mysore, 570015

India

Noble Hospital Pvt Ltd

Pune, 411013

India

Galaxy Lifecare Services Pvt. Ltd.

Varanasi, 201010

India

Azienda Ospedaliero Universitaria delle Marche

Ancona, 60126

Italy

Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

Bari, 70124

Italy

Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

A.O.U.Policlinico G.Martino

Messina, 98124

Italy

Asst Santi Paolo E Carlo

Milan, 20142

Italy

Fondazione Salvatore Maugeri

Pavia, 27100

Italy

IRCCS Ospedale "Casa Sollievo della Sofferenza"

San Giovanni Rotondo (FG), 71013

Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126

Italy

Kasugai Municipal Hospital

Aichi, Kasugai, 486-8510

Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Aichi, Nagoya, 466-8650

Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, Fukuoka, 815-8555

Japan

Kobe University Hospital

Hyogo, Kobe, 650-0017

Japan

The Jikei University Hospital

Tokyo, Minato-ku, 105-8471

Japan

Tokyo Women's Medical University Hospital

Tokyo, Shinjuku-ku, 162-8666

Japan

Hospital Selayang

Batu Caves, 68100

Malaysia

Hospital Sultan Idris Shah Serdang

Kajang, 43000

Malaysia

Sunway Medical Centre

Selangor Darul Ehsan, 47500

Malaysia

Centenario Hospital Miguel Hidalgo

Aguascalientes, 20259

Mexico

Health Pharma Professional Research S.A. de C.V.

Mexico City, 03100

Mexico

Soltmed Smo

Mexico City, 03650

Mexico

Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080

Mexico

Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal

Monterrey, 64060

Mexico

Instituto Nacional de Cardiologia Ignacio Chavez

Tlalpan, 14080

Mexico

Amsterdam UMC Locatie AMC

Amsterdam, 1105 AZ

Netherlands

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

Pacific Clinical Research Network - Auckland

Auckland, 622

New Zealand

Waikato Hospital

Hamilton, 3204

New Zealand

Akershus Universitetssykehus HF

Lørenskog, 1478

Norway

Oslo Universitetssykehus HF, Ulleval sykehus

Oslo, 0450

Norway

Helse Stavanger, Stavanger Universitetssykehus

Stavanger, N-4011

Norway

Universitetssykehuset Nord-Norge, Tromso

Tromsø, 9019

Norway

Central Clinical Hospital of the Medical University of Lodz

Lodz, 92-213

Poland

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

Poznan, 60-355

Poland

Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie

Szczecin, 70-111

Poland

Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie

Warsaw, 02-091

Poland

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Warsaw, 04-141

Poland

Unidade Local de Saúde de Almada-Seixal E.P.E.

Almada, 2805-267

Portugal

ULS Braga

Braga, 4710-243

Portugal

ULS de Santa Maria, E.P.E

Lisbon, 1649-035

Portugal

Unidade Local de Saúde Lisboa Occidental, E.P.E

Lisbon, 2790-134

Portugal

ULS de Loures-Odivelas, E.P.E

Loures, 2674-514

Portugal

Institutul Clinic Fundeni

Bucharest, 022328

Romania

County Emergency Hospital "Pius Brinzeu" Timisoara

Timișoara, 300723

Romania

Singapore General Hospital

Singapore, 169608

Singapore

Tan Tock Seng Hospital

Singapore, 308433

Singapore

F D Roosevelt University General Hospital Of Banska Bystrica

Banská Bystrica, 975 17

Slovakia

University Hospital and Comenius University in Bratislava, Derer´s Hospital

Bratislava, 833 05

Slovakia

Univerzitna nemocnica L. Pasteura Kosice

Košice, 04011

Slovakia

FMC Dialysis Services Kosice

Košice, 40190

Slovakia

Univerzitna Nemocnica Martin

Martin, 036 01

Slovakia

Kyung Hee University Hospital at Gangdong

Seoul, 05278

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950

Spain

Hospital Universitario Virgen de las Nieves

Granada, 18014

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Clinico De Valencia (INCLIVA)

Valencia, 46010

Spain

Danderyds Sjukhus

Danderyd, 182 88

Sweden

Universitetssjukhuset, Linköping

Linköping, 581 85

Sweden

Uppsala University Hospital

Uppsala, 751 85

Sweden

Klinik Hirslanden

Zurich, 8032

Switzerland

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 235

Taiwan

China Medical University Hospital

Taichung, 40447

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Taiwan University Hospital

Taipei, 100225

Taiwan

Adana City Hospital

Adana, 01220

Turkey (Türkiye)

Ankara Etlik City Hospital

Ankara, 06200

Turkey (Türkiye)

Bursa Uludag University

Bursa, 16110

Turkey (Türkiye)

Istanbul Capa University

Istanbul, 34093

Turkey (Türkiye)

Kocaeli University Faculty of Medicine Hospital

İzmit, 41000

Turkey (Türkiye)

Erciyes University

Melikgazi/Kayseri, 38039

Turkey (Türkiye)

Bradford Institute for Health Research

Bradford, BD9 6RJ

United Kingdom

The Royal London Hospital

London, E1 1BB

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

Salford Royal

Salford, M6 8HD

United Kingdom