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A study to evaluate the effects of BI 764198 in adults and adolescents with focal segmental glomerulosclerosis (FSGS)

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study investigates the effects of a medication called BI 764198 in people with Focal Segmental Glomerulosclerosis, which is a rare kidney disease that damages the small filtering units in the kidneys. The study specifically looks at individuals with primary focal segmental glomerulosclerosis or those with a version of the disease caused by TRPC6 gene mutations, which are changes in the genetic code that affect how the disease behaves. Some participants may also be taking a calcineurin inhibitor, which is a type of medicine used to manage certain immune-related conditions.

The purpose of the study is to determine if BI 764198 is more effective than a placebo at reducing the amount of protein leaked into the urine. During the study, participants will take either the active medication or a placebo in the form of an oral film-coated tablet. The treatment period lasts for 104 weeks, and the process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered during the trial.

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

    <b>randomization</b>

    You will be assigned to receive either the test medication, which is a film-coated tablet called BI 764198, or a placebo, which is a substance that looks like the medication but contains no active ingredients.

  2. Step 2

    <b>treatment period</b>

    The treatment will continue for a period of 104 weeks.

    During this time, the effectiveness of the medication is measured by looking at the 24-hour urinary protein-to-creatinine ratio, which is a test used to check the amount of protein in the urine over a full day.

  3. Step 3

    <b>assessment of outcomes</b>

    At week 104, the results are evaluated based on changes in urine protein levels and kidney function, which is measured by a test called eGFRcys.

    The study also monitors for complete remission, which is defined as having a urine protein level below 300 mg/g at the end of the 104 weeks.

Who can join the trial?

7 criteria

  • You must be a male or female aged 12 years or older on the day you sign the consent forms.
  • Your weight must be at least 40 kg (about 88 pounds).
  • Your Body Mass Index (BMI), which is a measure of body fat based on your height and weight, must be 40 or less.
  • You must have a confirmed diagnosis of focal segmental glomerulosclerosis (FSGS), which is a rare kidney disease, through either:
    • A biopsy (a procedure where a small piece of kidney tissue is removed to be examined under a microscope).
    • A genetic test showing a specific change, called a gain-of-function mutation, in the TRPC6 gene.
    • Your urinary protein-to-creatinine ratio (UPCR), which is a test that measures the amount of protein in your urine compared to a waste product called creatinine, must be 1500 mg/g or higher.
    • Your estimated glomerular filtration rate (eGFR), which is a calculation used to measure how well your kidneys are filtering waste from your blood, must be 25 mL/min/1.73 m2 or higher.

Who cannot join the trial?

5 criteria

  • You have a known genetic condition or a syndrome that causes focal segmental glomerulosclerosis (a type of kidney disease), unless it is specifically caused by a TRPC6 gain-of-function mutation (a specific type of change in a gene that makes it more active than normal).
  • There is evidence from a doctor or a histologic examination (a study of tissue samples under a microscope) that your kidney disease was caused by other factors, such as damage from toxins or other medical conditions.
  • Your kidney disease is classified as FSGS-UC, which means the cause of the disease is currently unknown, and this was diagnosed before your first visit to the study.
  • You have a history of receiving an organ transplant (an operation where a healthy organ is placed into your body to replace a damaged one) or if you are planning to have an organ transplant while participating in this study.
  • You have used intravenous immunosuppressive agents (medicines given directly into a vein to lower the body's immune system response) such as cyclophosphamide, rituximab, or obinutuzumab within the last 6 months before your first study visit.
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Investigated drugs

BI 764198 is an experimental medicine taken by mouth that works by inhibiting a specific protein in the body called TRPC6. This treatment is being studied to see if it can help reduce the amount of protein lost in the urine for people with certain types of kidney diseases known as focal segmental glomerulosclerosis.

What is already known about the treatment

  • BI 764198

    This medication is an experimental film-coated tablet taken by mouth to treat certain types of kidney diseases, such as focal segmental glomerulosclerosis. It belongs to a class of drugs known as TRPC6 inhibitors and works at a molecular level by blocking a specific protein channel in the kidney cells to prevent damage. While currently being studied in clinical trials, it aims to reduce the amount of protein leaked into the urine by regulating how cells manage minerals and fluids.

  • Placebo matching BI 764198

    This is an inactive substance administered in the same way as the test medication, which in this case is as a film-coated tablet taken by mouth. It contains no active medicinal ingredients and is used in clinical trials as a control to compare against the actual drug being tested. This allows researchers to determine if the changes observed in patients are truly caused by the experimental medication or by other factors.

Investigated diseases

Focal segmental glomerulosclerosis - This condition affects the small filtering units of the kidneys known as glomeruli. It is characterized by scarring in certain parts of these filters. As the disease progresses, the damage to the kidney structures can lead to increased amounts of protein being released into the urine. This process often results from damage to the specialized cells that help filter blood. Over time, the scarring can spread and affect the overall ability of the kidneys to function properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522191-86-00Protocol code1434-0017Estimated enrolment286 patientsSponsorBoehringer Ingelheim Espana S.A.

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