BI 764198 in Adults and Adolescents with Proteinuric Kidney Diseases

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What is this study about?

This clinical trial is studying proteinuric kidney diseases, which are kidney disorders that cause too much protein to leak into the urine. The study is testing BI 764198, an oral tablet, against a placebo matching BI 764198. The purpose of the study is to see whether BI 764198 is safe and helpful for adults and adolescents with four related kidney conditions: focal segmental glomerulosclerosis (a kidney disease that scars parts of the kidney filter), treatment-resistant primary minimal change disease (a kidney disease that does not improve with usual treatment), Alport syndrome (an inherited kidney disease that can also affect hearing and vision), and treatment-resistant primary membranous nephropathy (a kidney disease caused by damage to the kidney filters). Some participants may already be receiving other kidney medicines such as SGLT2i/CNI, which are drugs often used to protect kidney function and reduce protein loss in the urine.

The study is planned in two groups, and neither the participants nor the study team will know which treatment is given. After starting treatment, the medicine is taken for a period of time and then the study looks at changes in urine protein and kidney function over about 20 weeks. The study is designed to compare BI 764198 with placebo across the different kidney disease groups.

1 study treatment begins

After joining the study, you start one of two treatments in a 2-arm study. A 2-arm study means that participants are placed into one of two treatment groups.

You receive either BI 764198 or a placebo that matches BI 764198. A placebo is a tablet that looks like the study medicine but does not contain the active medicine.

BI 764198 is taken by mouth as a film-coated tablet.

The dose of BI 764198 is listed as 00 mg. The source data do not provide a route, frequency, or duration for the placebo or the exact dosing schedule for BI 764198.

2 treatment period through week 20

You continue the assigned study treatment during the trial period up to Week 20.

Some participants may also be on background SGLT2i/CNI treatment. SGLT2i means a sodium-glucose co-transporter 2 inhibitor, and CNI means a calcineurin inhibitor.

During this period, the study measures the change in 24-hour urinary protein-to-creatinine ratio (UPCR). UPCR is a urine test that compares protein and creatinine in urine and is used to measure how much protein is lost in the urine over 24 hours.

The study also checks whether your UPCR goes down by at least 25% or at least 40% from the start of treatment to Week 20.

The study measures the change in eGFR from the start of treatment to Week 20. eGFR means estimated glomerular filtration rate, which is a blood test-based measure of kidney function. In this study, it is based on cystatin C, a substance measured in blood.

3 week 20 assessment

At Week 20, the study compares your results with the start of treatment.

The main result is the relative change in 24-hour UPCR from the start of treatment to Week 20.

The study also records whether you had a treatment response defined as at least a 25% reduction in 24-hour UPCR or at least a 40% reduction in 24-hour UPCR.

The study records the change in eGFR from the start of treatment to Week 20.

Who Can Join the Study?

Male or female participants who are at least 18 years old, or at least 12 years old for the TR-pMCD group, when they sign the consent form or assent form. Consent means permission to take part in a study; assent means agreement from a minor.
A body mass index (BMI) of 40 kg/m² or less at the screening visit. BMI is a number based on height and weight.
A body weight of at least 40 kg at the screening visit.
An estimated glomerular filtration rate (eGFR) of at least 25 mL/min/1.73 m² at screening, measured using a blood test called serum cystatin C. eGFR is a measure of how well the kidneys are filtering blood.
For adults aged 18 years or older, the eGFR must be calculated with the CKD-EPI formula based on serum cystatin C.
For participants younger than 18 years, the eGFR must be calculated with the CKiD U25 formula using height and serum cystatin C.
A seated blood pressure, based on the average of 3 readings, with systolic blood pressure of 160 mmHg or less for adults, or 140 mmHg or less for participants younger than 18 years. Systolic blood pressure is the top number in a blood pressure reading.
Participants with a known history of white coat hypertension may still qualify if the investigator considers them medically stable and their usual blood pressure can be considered within the limits above. White coat hypertension means blood pressure that is higher in a medical setting because of stress or anxiety.
Participants must already be taking an ACE inhibitor or an ARB at a stable, optimized dose for at least 8 weeks before screening, with no plan to change the dose until the end of the randomised treatment period unless the doctor decides it is needed or it is not tolerated. ACE inhibitors and ARBs are medicines often used to protect the kidneys and lower blood pressure.
If participants are taking a non-steroidal mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonist (ERA), GLP-1 medicine, or SGLT2 inhibitor, the dose must have been stable for at least 8 weeks before screening, and it is preferred that the dose does not change until the end of the double-blind treatment period. These are medicines used for kidney, heart, diabetes, or blood pressure-related care.
Participants taking oral immunosuppressive therapy other than glucocorticoids must have been on a stable dose for at least 12 weeks before screening, with no plan to change the dose during the trial treatment period. Immunosuppressive therapy means medicine that lowers immune system activity; glucocorticoids are a type of steroid medicine.
They must meet any additional inclusion requirements used by the study.

Who Cannot Join the Study?

A history of organ transplantation (having received a donated organ), or a plan to have a transplant during the study.
Use of intravenous immunosuppressive medicines in the past 6 months before the screening visit. These are medicines given through a vein that lower the immune system, such as cyclophosphamide, rituximab, or obinutuzumab.
If the study doctor expects that you will need to start oral or intravenous immunosuppressive treatment during the trial. Oral means taken by mouth; intravenous means given through a vein.
Use of metformin or dofetilide within 1 week before randomization and until 5 days after the end-of-treatment visit. These medicines are called MATE1 substrates, which means they use the same body transport pathway as the study treatment.
Use of strong CYP3A4/5 inhibitors or CYP3A4/5 inducers within 1 week before randomization, or within 5 half-lives of the medicine if that is longer. These are medicines that can greatly change how other medicines are broken down by the body.
ALT or AST liver blood test results more than 3 times the upper limit of normal at screening. ALT and AST are enzymes measured to check liver health.
Any other important laboratory abnormality or medical condition that, in the investigator’s opinion, could be unsafe or could interfere with the study results. The only exception is kidney test changes related to the kidney disease being studied.
A QTcF interval above 450 milliseconds in males or above 470 milliseconds in females, or any other important ECG finding at screening. QTcF is a heart rhythm measurement on an electrocardiogram, and ECG is a heart tracing test.
Any other exclusion criteria not listed here that apply in the full study rules.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Oslo Universitetssykehus HF	Oslo	Norway
Medizinische Hochschule Hannover	Hanover	Germany
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Spitalul Clinic Judetean De Urgenta Pius Brinzeu	Timisoara	Romania
Univerzitna nemocnica L. Pasteura Kosice	Kosice	Slovakia
Region Sjaelland	Holbæk	Denmark
Tartu University Hospital	Tartu	Estonia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
General University Hospital Of Patras	Patras	Greece
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Specijalna Bolnica Medico	Rijeka	Croatia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oestergoetland	Linkoping	Sweden
University Hospital Sveti Duh	Zagreb	Croatia
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Helse Stavanger HF	Stavanger	Norway
Az Maria Middelares Gent	Gent	Belgium
Univerzitna Nemocnica Martin	Martin	Slovakia
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
University General Hospital Of Heraklion	Heraklion	Greece
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie	Warsaw	Poland
Azorg	Aalst	Belgium
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Fundeni Clinical Institute	Bucharest	Romania
Uzyjescyqifgf Swielbq Ksghxwqsi No 2 Pum W Svylcxshuk	Szczecin	Poland
Hvlxkpde Vfpo dctmlafd	Barcelona	Spain
Ukdpwkkkzo Hrxfafxq Cykujrx	Cologne	Germany
Ajaaqnugy Ukt	Amsterdam	The Netherlands
Acadoumi Uuuxyivlhn Hpldcrmc	Lorenskog	Norway
Uhmwlsp Ukhatkyryh Hxbgtngm	Uppsala	Sweden
Aevairt Udxly Snvieahwi Lbdrrf Dd Bozlkni	Bologna	Italy
Uzvbcfffnl Meizehw Cmspnu Hntedynkzsscwapdy	Hamburg	Germany
Uqfhgeihdvgn Mtwagnu Cufadue Gplxtmvpz	Groningen	The Netherlands
Cedhsvyn Hktxqcot Drupwhc	Zagreb	Croatia
Fxj dssttcjxgj sayang stytpi	Kosice	Slovakia
Ozjm Zfnxeaqeok Brtyoah Vonrnkso	Vinkovci	Croatia

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	15.06.2026
Croatia	Not yet recruiting	15.06.2026
Denmark	Not yet recruiting	15.06.2026
Estonia	Not yet recruiting	15.06.2026
France	Not yet recruiting	15.06.2026
Germany	Not yet recruiting	15.06.2026
Greece	Not yet recruiting	15.06.2026
Italy	Not yet recruiting	15.06.2026
Norway	Not yet recruiting	15.06.2026
Poland	Not yet recruiting	15.06.2026
Portugal	Not yet recruiting	15.06.2026
Romania	Not yet recruiting	15.06.2026
Slovakia	Not yet recruiting	15.06.2026
Spain	Recruiting	15.06.2026
Sweden	Not yet recruiting	15.06.2026
The Netherlands	Not yet recruiting	15.06.2026

Trial locations

Investigated drugs:

[4-(6-Aminopyridazin-3-Yl)Piperidin-1-Yl][5-(4-Fluorophenoxy)-4-Methoxypyridin-2-Yl]Methanone

BI 764198 is the study medicine being tested in this trial. It is an oral tablet taken by mouth and is being studied to see if it can help lower protein in the urine and improve kidney disease. Researchers are also checking how safe it is, how well people tolerate it, and how the body handles it over time.

Investigated diseases:

Renal disorder

Proteinuric kidney disease – Proteinuric kidney disease is a group of kidney disorders in which too much protein passes into the urine because the kidney filters are damaged. It often develops gradually, with increasing protein loss over time and, in some cases, a slow decline in kidney function. The condition can be caused by different underlying kidney diseases, including glomerular disorders.

Trial ID:

2025-523425-17-00

Protocol code:

1434-0027

Trial Phase:

Therapeutic exploratory (Phase II)

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BI 764198 in Adults and Adolescents with Proteinuric Kidney Diseases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?