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BI 764198 in Adults and Adolescents with Proteinuric Kidney Diseases

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

9 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

  • Placebo matching BI 764198

    This is an inactive tablet made to look like the study medicine and is taken by mouth in the same way as the active drug. It has no known medicinal effect and is used in clinical trials to compare results fairly and to help show whether the real treatment works. Because it contains no active substance, it does not have a true pharmacological class or a mechanism of action in the body, and it is not used to treat kidney disease outside research settings.

  • BI 764198

    BI 764198 is an oral film-coated tablet taken by mouth, and in this study it is being tested for use in people with proteinuric kidney diseases. It is an investigational medicine, so its full role in regular medical practice is still being studied in clinical trials and medical literature; it is not yet a standard treatment. It is being developed to reduce protein loss in the urine in conditions such as focal segmental glomerulosclerosis, minimal change disease, Alport syndrome, and membranous nephropathy, and it appears to work by blocking a specific protein signal involved in kidney damage and inflammation at the cell level. Its pharmacological class is still considered experimental, but it is generally described as a targeted small-molecule kidney medicine.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523425-17-00Protocol code1434-0027Estimated enrolment149 patientsSponsorBoehringer Ingelheim Espana S.A.

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