New kidney drug shows promise in reducing protein leakage

NCT ID NCT07355296

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 14 times

Summary

This study tests an experimental tablet, BI 764198, in adults and some teens with four types of kidney disease that cause protein in the urine. Participants take the drug or a placebo daily for 20 weeks while continuing their usual care. The main goal is to see if the drug lowers protein levels in urine, a sign of kidney damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alport syndrome focal segmental glomerulosclerosis idiopathic membranous glomerulonephritis lipoid nephrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Proteinuric kidney diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

164 sites in 33 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

A.O.U.Policlinico G.Martino
NOT_YET_RECRUITING

Messina, 98124, Italy
AIIMS Bhubaneshwar
NOT_YET_RECRUITING

Bhubaneswar, 751019, India
AZORG Ziekenhuis
RECRUITING

Aalst, 9300, Belgium
Aartham Multi Super Speciality Hospital
NOT_YET_RECRUITING

Ahmedabad, 380015, India
Academic Medical Research Institute - Glendale
RECRUITING

Los Angeles, California, 90022, United States
Adana City Hospital
NOT_YET_RECRUITING

Adana, 01220, Turkey (Türkiye)
Ajou University Hospital
RECRUITING

Suwon, 16499, South Korea
Akershus Universitetssykehus HF
RECRUITING

Lørenskog, 1478, Norway
Amicis Research Center - Balboa
RECRUITING

Granada Hills, California, 91344, United States
Amsterdam UMC Locatie AMC
NOT_YET_RECRUITING

Amsterdam, 1105 AZ, Netherlands
Ankara Etlik City Hospital
NOT_YET_RECRUITING

Ankara, 06200, Turkey (Türkiye)
Ann & Robert H. Lurie Children's Hospital of Chicago
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Asst Santi Paolo E Carlo
RECRUITING

Milan, 20142, Italy
Az Maria Middelares Gent
RECRUITING

Ghent, 9000, Belgium
Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING

Verona, 37126, Italy
Azienda Ospedaliero Universitaria delle Marche
NOT_YET_RECRUITING

Ancona, 60126, Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
NOT_YET_RECRUITING

Bari, 70124, Italy
Beijing Tsinghua Changgung Hospital
RECRUITING

Beijing, 102218, China
Bradford Institute for Health Research
RECRUITING

Bradford, BD9 6RJ, United Kingdom
Bursa Uludag University
NOT_YET_RECRUITING

Bursa, 16110, Turkey (Türkiye)
CHU Amiens-Picardie
RECRUITING

Amiens, 80054, France
CTR Oakwater, LLC
RECRUITING

Orlando, Florida, 32806, United States
CaRe Clinic (Calgary)
RECRUITING

Calgary, Alberta, T2N 4L7, Canada
CardioAlem Investigaciones
RECRUITING

San Isidro, B1642DCD, Argentina
Centenario Hospital Miguel Hidalgo
NOT_YET_RECRUITING

Aguascalientes, 20259, Mexico
Central Clinical Hospital of the Medical University of Lodz
NOT_YET_RECRUITING

Lodz, 92-213, Poland
Centro Medico Dra Laura Maffei
RECRUITING

Ciudad Autonoma Buenos Aires, C1425AGC, Argentina
China Medical University Hospital
RECRUITING

Taichung, 40447, Taiwan
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Clinica Privada Velez Sarfield
RECRUITING

Córdoba, 5000, Argentina
Clinical Hospital Sveti Duh
RECRUITING

Zagreb, 10000, Croatia
Colorado Kidney Care
RECRUITING

Denver, Colorado, 80220, United States
Concord Repatriation General Hospital
NOT_YET_RECRUITING

Concord, New South Wales, 2139, Australia
County Emergency Hospital "Pius Brinzeu" Timisoara
RECRUITING

Timișoara, 300723, Romania
Danderyds Sjukhus
RECRUITING

Danderyd, 182 88, Sweden
Duke University Medical Center
NOT_YET_RECRUITING

Durham, North Carolina, 27710, United States
Endeavor Health
NOT_YET_RECRUITING

Evanston, Illinois, 60201, United States
Erciyes University
NOT_YET_RECRUITING

Melikgazi/Kayseri, 38039, Turkey (Türkiye)
F D Roosevelt University General Hospital Of Banska Bystrica
NOT_YET_RECRUITING

Banská Bystrica, 975 17, Slovakia
FMC Dialysis Services Kosice
NOT_YET_RECRUITING

Košice, 40190, Slovakia
Florida Kidney Physicians - Boca Raton
RECRUITING

Boca Raton, Florida, 33487, United States
Florida Kidney Physicians - Riverview/Brandon
RECRUITING

Riverview, Florida, 33578, United States
Florida Kidney Physicians, LLC - Fort Lauderdale
RECRUITING

Fort Lauderdale, Florida, 33316, United States
Fondazione Salvatore Maugeri
RECRUITING

Pavia, 27100, Italy
Fundacao Oswaldo Ramos (Hospital do Rim)
RECRUITING

São Paulo, 04038-002, Brazil
Galaxy Lifecare Services Pvt. Ltd.
NOT_YET_RECRUITING

Varanasi, 201010, India
General Hospital Vinkovci
RECRUITING

Vinkovci, 32100, Croatia
General University Hospital of Patras
NOT_YET_RECRUITING

Pátrai, 265 04, Greece
Government Medical College
NOT_YET_RECRUITING

Kozhikode, 673008, India
Guangdong Provincial People's Hospital
RECRUITING

Guangzhou, 510080, China
HOP Pellegrin
RECRUITING

Bordeaux, 33076, France
Health Pharma Professional Research S.A. de C.V.
NOT_YET_RECRUITING

Mexico City, 03100, Mexico
Helse Stavanger, Stavanger Universitetssykehus
NOT_YET_RECRUITING

Stavanger, N-4011, Norway
Hopital Erasme
NOT_YET_RECRUITING

Brussels, 1070, Belgium
Hopital Henri Mondor
RECRUITING

Créteil, 94000, France
Hopital Necker
RECRUITING

Paris, 75015, France
Hopital Pasteur
RECRUITING

Nice, 06000, France
Hospital Clinico De Valencia (INCLIVA)
NOT_YET_RECRUITING

Valencia, 46010, Spain
Hospital Sant Joan de Déu
NOT_YET_RECRUITING

Esplugues de Llobregat, 08950, Spain
Hospital Selayang
RECRUITING

Batu Caves, 68100, Malaysia
Hospital Sultan Idris Shah Serdang
RECRUITING

Kajang, 43000, Malaysia
Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Virgen de las Nieves
RECRUITING

Granada, 18014, Spain
Hospital das Clínicas da Faculdade de Medicina da USP
RECRUITING

São Paulo, 05403-000, Brazil
Hospital de Clinicas de Porto Alegre
RECRUITING

Porto Alegre, 90035-903, Brazil
IRCCS Ospedale "Casa Sollievo della Sofferenza"
NOT_YET_RECRUITING

San Giovanni Rotondo (FG), 71013, Italy
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING

Mexico City, 14080, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
NOT_YET_RECRUITING

Tlalpan, 14080, Mexico
Instituto da Crianca e do Adolescente
NOT_YET_RECRUITING

São Paulo, 05403-901, Brazil
Institutul Clinic Fundeni
RECRUITING

Bucharest, 022328, Romania
Istanbul Capa University
NOT_YET_RECRUITING

Istanbul, 34093, Turkey (Türkiye)
JSS Medical College
NOT_YET_RECRUITING

Mysore, 570015, India
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
RECRUITING

Aichi, Nagoya, 466-8650, Japan
Japanese Red Cross Fukuoka Hospital
RECRUITING

Fukuoka, Fukuoka, 815-8555, Japan
John Hunter Hospital
RECRUITING

New Lambton Heights, New South Wales, 2305, Australia
Johns Hopkins Hospital
NOT_YET_RECRUITING

Baltimore, Maryland, 21287, United States
Kasugai Municipal Hospital
RECRUITING

Aichi, Kasugai, 486-8510, Japan
Kidney Disease Medical Group
RECRUITING

Glendale, California, 91206, United States
King's College Hospital
RECRUITING

London, SE5 9RS, United Kingdom
Klinik Hirslanden
RECRUITING

Zurich, 8032, Switzerland
Klinikum rechts der Isar der Technischen Universität München
NOT_YET_RECRUITING

München, 81675, Germany
Kobe University Hospital
RECRUITING

Hyogo, Kobe, 650-0017, Japan
Kocaeli University Faculty of Medicine Hospital
NOT_YET_RECRUITING

İzmit, 41000, Turkey (Türkiye)
Kyung Hee University Hospital at Gangdong
RECRUITING

Seoul, 05278, South Korea
Maisonneuve-Rosemont Hospital
NOT_YET_RECRUITING

Monteral, Quebec, H1T 2M4, Canada
Medizinische Hochschule Hannover
RECRUITING

Hanover, 30625, Germany
NYU Langone Nephrology Associates-Mineola
RECRUITING

Mineola, New York, 11501, United States
National Taiwan University Hospital
RECRUITING

Taipei, 100225, Taiwan
Nationwide Children's Hospital
NOT_YET_RECRUITING

Columbus, Ohio, 43205, United States
Nepean Hospital
RECRUITING

Kingswood, New South Wales, 2747, Australia
Nephrology Consultants, LLC
RECRUITING

Huntsville, Alabama, 35805, United States
Nephrotex Research Group
NOT_YET_RECRUITING

Dallas, Texas, 75231, United States
New York Nephrology and Dialysis Access Surgery, PC
RECRUITING

Clifton Park, New York, 12065, United States
Nizam's Institute of Medical Sciences
NOT_YET_RECRUITING

Hyderabad, 500082, India
Noble Hospital Pvt Ltd
NOT_YET_RECRUITING

Pune, 411013, India
Northeast Clinical Research Center
NOT_YET_RECRUITING

Bethlehem, Pennsylvania, 18017, United States
Oslo Universitetssykehus HF, Ulleval sykehus
RECRUITING

Oslo, 0450, Norway
Osmania Medical College & Hospital
NOT_YET_RECRUITING

Hyderabad, 500012, India
Pacific Clinical Research Network - Auckland
RECRUITING

Auckland, 622, New Zealand
Peking University First Hospital
RECRUITING

Beijing, 100034, China
People's Hospital of Sichuan Province
RECRUITING

Sichuan, 610031, China
Policlinico S. Orsola-Malpighi
RECRUITING

Bologna, 40138, Italy
Princess Alexandra Hospital
RECRUITING

Woolloongabba, Queensland, 4102, Australia
Provecta Researh Network
RECRUITING

Houston, Texas, 77027, United States
Queens Long Island Kidney Center
NOT_YET_RECRUITING

Fresh Meadows, New York, 11366, United States
Renmin Hospital of Wuhan University
RECRUITING

Wuhan, 430060, China
Royal Brisbane and Women's Hospital
RECRUITING

Brisbane, Queensland, 4029, Australia
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
RECRUITING

Shanghai, 200025, China
Salford Royal Hospital
RECRUITING

Salford, M6 8HD, United Kingdom
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
NOT_YET_RECRUITING

Warsaw, 02-091, Poland
Sanjay Gandhi Post Graduate Institute of Medical Sciences
NOT_YET_RECRUITING

Lucknow, 226014, India
Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal
NOT_YET_RECRUITING

Monterrey, 64060, Mexico
Shanghai General Hospital
RECRUITING

Shanghai, 200080, China
Singapore General Hospital
RECRUITING

Singapore, 169608, Singapore
Solmed Polyclinic
RECRUITING

Zagreb, 10000, Croatia
Soltmed Smo
NOT_YET_RECRUITING

Mexico City, 03650, Mexico
Southeast Renal Research Institute
RECRUITING

Chattanooga, Tennessee, 37404, United States
Specijalna Bolnica Medico
NOT_YET_RECRUITING

Rijeka, 51000, Croatia
St. Clair Nephrology Research, LLC - Shelby Township
RECRUITING

Shelby, Michigan, 48315, United States
Sunway Medical Centre
RECRUITING

Selangor Darul Ehsan, 47500, Malaysia
Taichung Veterans General Hospital
RECRUITING

Taichung, 40705, Taiwan
Taipei Medical University-Shuang Ho Hospital
RECRUITING

New Taipei City, 235, Taiwan
Tan Tock Seng Hospital
RECRUITING

Singapore, 308433, Singapore
Tartu University Hospital
NOT_YET_RECRUITING

Tartu, 50406, Estonia
Terapia Renal Domiciliaria
RECRUITING

Buenos Aires, 1407, Argentina
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, 330006, China
The First People's Hospital of Nanning
RECRUITING

Nanning, 530000, China
The Jikei University Hospital
RECRUITING

Tokyo, Minato-ku, 105-8471, Japan
The Royal London Hospital
RECRUITING

London, E1 1BB, United Kingdom
Tokyo Women's Medical University Hospital
RECRUITING

Tokyo, Shinjuku-ku, 162-8666, Japan
Total Research Group, LLC
RECRUITING

Miami, Florida, 33126, United States
ULS de Braga, E.P.E
RECRUITING

Braga, 4710-243, Portugal
ULS de Loures-Odivelas, E.P.E
RECRUITING

Loures, 2674-514, Portugal
ULS de Santa Maria, E.P.E
RECRUITING

Lisbon, 1649-035, Portugal
UZ Leuven
RECRUITING

Leuven, 3000, Belgium
Unidade Local de Saúde Lisboa Occidental, E.P.E
RECRUITING

Lisbon, 2790-134, Portugal
Unidade Local de Saúde de Almada-Seixal E.P.E.
RECRUITING

Almada, 2805-267, Portugal
Universidade Federal do Ceara
RECRUITING

Fortaleza, 60110-110, Brazil
Universitair Medisch Centrum Groningen
NOT_YET_RECRUITING

Groningen, 9713 GZ, Netherlands
Universitetssjukhuset Linköping
RECRUITING

Linköping, 581 85, Sweden
Universitetssykehuset Nord-Norge, Tromso
NOT_YET_RECRUITING

Tromsø, 9019, Norway
University General Hospital of Heraklion
NOT_YET_RECRUITING

Heraklion, 71500, Greece
University Hospital Dubrava
RECRUITING

Zagreb, 10000, Croatia
University Hospital and Comenius University in Bratislava, Derer´s Hospital
NOT_YET_RECRUITING

Bratislava, 833 05, Slovakia
University of California Los Angeles
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
Universitätsklinikum Hamburg, Eppendorf
RECRUITING

Hamburg, 20246, Germany
Universitätsklinikum Hamburg, Eppendorf
NOT_YET_RECRUITING

Hamburg, 20246, Germany
Universitätsklinikum Köln (AöR)
RECRUITING

Cologne, 50937, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
NOT_YET_RECRUITING

Mainz, 55131, Germany
Univerzitna Nemocnica Martin
RECRUITING

Martin, 036 01, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
RECRUITING

Košice, 04011, Slovakia
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
NOT_YET_RECRUITING

Szczecin, 70-111, Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
NOT_YET_RECRUITING

Poznan, 60-355, Poland
Uppsala University Hospital
RECRUITING

Uppsala, 751 85, Sweden
Victoria Hospital (LHSC)
RECRUITING

London, Ontario, N6A 5W9, Canada
Vivantes Klinikum im Friedrichshain
NOT_YET_RECRUITING

Berlin, 10249, Germany
Waikato Hospital
NOT_YET_RECRUITING

Hamilton, 3204, New Zealand
West China Hospital, Sichuan University
RECRUITING

Chengdu, 610041, China
West Virginia University Medicine
NOT_YET_RECRUITING

Morgantown, West Virginia, 26506, United States
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
RECRUITING

Warsaw, 04-141, Poland
Zealand University Hospita; Roskilde
NOT_YET_RECRUITING

Roskilde, 4000, Denmark
Zhongda Hospital Southeast University
RECRUITING

Nanjing, 210009, China
Zhongshan Hospital Affiliated to Xiamen University
RECRUITING

Xiamen, 361004, China

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