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Study of BI 764198 for Patients with Focal Segmental Glomerulosclerosis

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What is this trial about?

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

This clinical study focuses on a kidney disease called focal segmental glomerulosclerosis (FSGS), which affects the filtering units in the kidneys. Patients with this condition often experience increased levels of protein in their urine, a condition known as proteinuria. The purpose of this study is to evaluate whether a new drug, BI 764198, can help reduce the amount of protein in the urine of patients suffering from FSGS.

The study involves taking BI 764198 in the form of a capsule, which is taken orally once a day for 12 weeks. Some participants in the study may receive a placebo, a substance with no active therapeutic effect, to compare its effects with those of the actual drug. This is a common practice in clinical studies to ensure accurate results. The scientists will monitor patients closely to assess the effectiveness, safety, and tolerance of the drug. The aim is to find out if BI 764198 can reduce proteinuria in people with FSGS. Participants will undergo regular check-ups and tests to provide researchers with necessary information.

The capsule form makes the drug easy to administer and ensures that participants can continue with their daily activities during the study. This research will provide valuable insight into whether BI 764198 can be a beneficial treatment option for patients with focal segmental glomerulosclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide signed and dated informed consent. This is a formal agreement to participate in the study, acknowledging understanding of the study's purpose and procedures.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility. This includes verifying age (18 to 75 years), diagnosis of focal segmental glomerulosclerosis (FSGS), and a urine protein-creatinine ratio (UPCR) of at least 1000 mg/g.

    The patient must have a stable dose of any corticosteroids or other specified medications for at least 4 weeks prior to this assessment.

  3. Step 3

    Medication administration

    The patient receives the study medication, BI 764198, or a placebo. The medication is administered orally in the form of a capsule.

    The patient takes the medication once daily for a duration of 12 weeks.

  4. Step 4

    Monitoring and follow-up

    Throughout the 12-week period, the patient's health and response to the medication are monitored. This includes regular assessments of the 24-hour urine protein-creatinine ratio (UPCR) to evaluate changes from baseline.

    Blood samples are taken to measure the pre-dose plasma concentration of BI 764198 at weeks 4 and 12.

  5. Step 5

    Completion of the study

    At the end of the 12-week period, the study concludes with a final assessment. The primary goal is to determine if there is at least a 25% reduction in the 24-hour UPCR compared to the baseline measurement.

    Secondary outcomes include further analysis of changes in UPCR and urinary protein excretion.

Who can join the trial?

8 criteria

  • You must sign and date a form that shows you understand the study and agree to take part.
  • You need to be between 18 and 75 years old.
  • You should have been diagnosed with a condition called focal segmental glomerulosclerosis (FSGS), which is confirmed by a test called a biopsy, or have a specific gene change known to cause FSGS.
  • Your urine test should show a protein-creatinine ratio of 1000 mg/g or higher. This test measures the amount of protein in your urine.
  • If you are taking corticosteroids (a type of medication), your dose should not have changed for at least 4 weeks before starting the study, and there should be no plans to change it during the study.
  • If you are taking certain medications like ACE inhibitors, ARBs, finerenone, aldosterone inhibitors, or SGLT2 inhibitors, your dose should not have changed for at least 4 weeks before starting the study, and there should be no plans to change it during the study.
  • Your Body Mass Index (BMI), which is a measure of body fat based on height and weight, should be 40 or less.
  • If you are a woman who can have children, you must agree to use very effective birth control methods that have a low chance of failing, less than 1% per year, if used correctly. The study will provide a list of acceptable methods.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to the study medication are excluded.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Those with severe liver disease cannot take part in the study.
  • Individuals with a history of drug or alcohol abuse in the past year are excluded.
  • Patients currently participating in another clinical trial are not eligible.
  • Individuals with a history of cancer in the past five years, except for certain skin cancers, cannot participate.
  • Patients with severe heart disease are excluded from the study.
  • Individuals with a history of kidney transplant are not eligible.
  • Patients with active infections requiring treatment are excluded.
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Investigated drugs

BI 764198 is a medication being studied for its potential to reduce protein levels in the urine of patients with a kidney condition called focal segmental glomerulosclerosis. This condition can lead to kidney damage, and the medication is taken orally once a day for 12 weeks to assess its effectiveness, safety, and how well patients tolerate it.

What is already known about the treatment

BI 764198 – This medication is administered orally once daily and is currently being studied in clinical trials for its effectiveness in treating focal segmental glomerulosclerosis, a kidney disorder. The main therapeutic indication is to reduce proteinuria, which is the presence of excess protein in the urine. At the molecular level, BI 764198 works by modulating specific pathways that affect kidney function, although the exact mechanism is still under investigation. It is classified pharmacologically as a potential treatment for kidney diseases, and its safety and efficacy are being evaluated in ongoing research.

Investigated diseases

Focal Segmental Glomerulosclerosis – This is a kidney disorder characterized by scarring in some of the glomeruli, which are tiny structures within the kidneys that filter waste from the blood. The disease can lead to proteinuria, where excess protein is found in the urine due to the kidneys' impaired filtering ability. Over time, this condition can cause the kidneys to lose their ability to function properly. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid progression. Symptoms may include swelling in parts of the body, high blood pressure, and foamy urine. The exact cause of the disease is often unknown, but it can be associated with other conditions or genetic factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511706-23-00Protocol code1434-0004Estimated enrolment63 patientsSponsorBoehringer Ingelheim International GmbH

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