Study of BI 764198 for Patients with Focal Segmental Glomerulosclerosis

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Fundacio Puigvert	Barcelona	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Udewqnaeugkvkckgyqder Esnmo Ajt	Essen	Germany
Ufxuxnlhts Hiuimmbq Cpbzuqc	Cologne	Germany
Abcshmgneb Ppkqeqsk Hlnnxerr Dd Mqlrjgiju	Marseille	France
Kroccxsb dgu Uipgkucwelno Mktkpvrb Aoy	Munich	Germany
Azvflop Uhvrq Sekuxxfka Lcwvnv Ds Btfwzge	Bologna	Italy
Hisuivha Uepnssvxxveoc Hvsmupzl Tnrvb y Ptnhss Ikkvmdsi Clitwf dcuppoggbyguygbqb (rjku	Badalona	Spain
Hzpellux Vagn dyhgfdlg	Barcelona	Spain
Cmd Kohjinn Bylrmef	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	07.09.2022
France	Not recruiting	07.09.2022
Germany	Not recruiting	07.09.2022
Italy	Not recruiting	07.09.2022
Spain	Not recruiting	07.09.2022

Trial locations

Investigated drugs:

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

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.

Investigated diseases:

Focal segmental glomerulosclerosis

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 ID:

2024-511706-23-00

Protocol code:

1434-0004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of BI 764198 for Patients with Focal Segmental Glomerulosclerosis

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