BI 764198 for Nephrotic Syndrome

Not yet recruiting at 125 trial locations

Overseen By Boehringer Ingelheim

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: ACE inhibitors, ARBs

Must not be taking: Metformin, Dofetilide

Disqualifiers: Organ transplantation, Strong CYP3A4/5 inhibitors, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the medication BI 764198 can aid individuals with certain kidney problems, such as secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. Participants are randomly assigned to take either the medication or a placebo (a pill resembling the medicine but without active ingredients) daily for 20 weeks while continuing their usual treatment. The goal is to determine if BI 764198 improves kidney health by comparing test results between the two groups. Suitable candidates for this trial are those who have struggled with these specific kidney conditions despite treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You can continue taking your current medications for your kidney condition during the study. However, you need to be on a stable dose of certain medications like ACE inhibitors, ARBs, and others for a specific period before joining the trial, and there should be no plans to change the dose during the trial.

Is there any evidence suggesting that BI 764198 is likely to be safe for humans?

Research has shown that BI 764198, the treatment being tested in this trial, demonstrated promising safety results in earlier studies. For instance, one study found that BI 764198 was well tolerated by participants over 12 weeks, with most experiencing no serious side effects. Another study confirmed that BI 764198 could be taken with or without food and remained well tolerated.

These findings suggest that BI 764198 might be safe for people with different kidney conditions. However, since this is a clinical trial, researchers will closely monitor any side effects that may occur to ensure the treatment's safety for all participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BI 764198 is unique because it offers a fresh approach to treating nephrotic syndrome by specifically targeting the TRPC5 ion channels in kidney cells. Unlike current treatments like corticosteroids and immunosuppressants, which broadly suppress the immune system, BI 764198 directly addresses the pathways involved in kidney damage. Researchers are excited about this treatment because it has the potential to minimize side effects while effectively reducing proteinuria, a hallmark of nephrotic syndrome. This targeted mechanism could lead to more precise therapy, improving outcomes for patients with conditions like secondary focal segmental glomerulosclerosis, Alport Syndrome, and treatment-resistant primary nephropathies.

What evidence suggests that BI 764198 might be an effective treatment for nephrotic syndrome?

Research has shown that BI 764198, which participants in this trial may receive, may help treat kidney problems like secondary focal segmental glomerulosclerosis (sFSGS). In earlier studies, patients who took a 20-mg dose of BI 764198 experienced a significant decrease in protein in their urine, an important indicator of kidney health. The likelihood of this improvement was ten times higher compared to those who took a placebo. The treatment targets specific parts of kidney cells to enhance their function and longevity. This suggests that BI 764198 could effectively manage these challenging kidney conditions. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults and adolescents with specific kidney diseases such as sFSGS, TR-pMCD, AS, and TR-pMN can join this trial. They must be over 18 (or over 12 for TR-pMCD), have a BMI ≤40 kg/m2, weigh ≥40 kg, and have stable kidney function. Participants should be on certain blood pressure or kidney medications for at least 8 weeks before joining.

Inclusion Criteria

I am under 18 and my kidney function is good based on a specific test.

I've been on a stable dose of my immunosuppressive medication, other than steroids, for 12 weeks.

My blood pressure is stable and within the required range for my age.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a tablet once a day for 20 weeks, with regular monitoring of protein levels in urine and kidney function

20 weeks

6 visits (in-person), 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 764198

Trial Overview

The study tests if BI 764198 tablets help with these kidney conditions compared to placebo tablets. Participants are randomly assigned to either the treatment or placebo group in a ratio of two-to-one favoring the treatment group. The trial lasts about seven months with regular visits and phone calls to monitor urine protein levels and kidney function.

How Is the Trial Designed?

Group I: Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort Experimental Treatment 1 Intervention

Group II: Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort Experimental Treatment 1 Intervention

Group III: Secondary focal segmental glomerulosclerosis (sFSGS) cohort Experimental Treatment 1 Intervention

Group IV: Alport Syndrome cohort Experimental Treatment 1 Intervention

Group V: Placebo cohort Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1.

boehringer-ingelheim.com

boehringer-ingelheim.com/human-health/chronic-kidney-disease/boehringer-announces-phase-2-results-fsgs-rare-kidney-disease

Boehringer announces Phase 2 results in FSGS rare ...

Phase II trial results, published in The Lancet, demonstrated a 40% reduction in proteinuria with apecotrep (20 mg dose group) compared to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10719596/

TRPC6 Inhibitor BI 764198 in Focal Segmental ... - PMC - NIH

Through its unique mechanism of action as a selective inhibitor of TRPC6, BI 764198 is expected to improve podocyte function and survival in patients with ...

3.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(25)02255-X/abstract

a randomised, placebo-controlled, phase 2 trial of BI 764198

BI 764198 lowered proteinuria and was well tolerated by participants in this trial. This is the first evidence of efficacy with a podocyte- ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07220083

NCT07220083 | A Study to Find Out if BI 764198 Helps ...

This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find ...

5.

docwirenews.com

docwirenews.com/post/podocyte-targeted-therapy-shows-efficacy-for-patients-with-fsgs

Podocyte-Targeted Therapy Shows Efficacy for Patients ...

“BI 764198 lowered proteinuria in FSGS and was well tolerated,” the researchers said. “This is the first evidence of efficacy with a podocyte- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07355296

PODOMOUNT-Basket, a Study to Test Whether BI 764198 ...

This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05213624

NCT05213624 | A Study to Test BI 764198 in People With ...

The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS.

8.

medicine.osu.edu

medicine.osu.edu/departments/internal-medicine/nephrology/research

Nephrology Research | Ohio State College of Medicine

Alport Syndrome. Study Name: R3R01 Title: A Phase II, Multi-center, Open-Label Study to Assess Safety ... BI 764198 administered orally once daily for 12 ...