BI 764198 for Focal Segmental Glomerulosclerosis

Not yet recruiting at 182 trial locations

Overseen By Boehringer Ingelheim

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Standard FSGS medications

Must not be taking: Intravenous immunosuppressives

Disqualifiers: Organ transplant history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 3

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new medicine, BI 764198, can help people with focal segmental glomerulosclerosis (FSGS), a kidney condition that can lead to serious health issues. Participants will be divided into two groups: one taking the actual medicine and the other taking a placebo, which looks like the medicine but contains no active ingredients. The goal is to determine if BI 764198 improves kidney health compared to the placebo. Those diagnosed with FSGS from a kidney biopsy or genetic test, and who have high protein levels in their urine, might be suitable candidates for this study. Participants will continue their regular FSGS medication and visit the study site every three months for up to two years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

No, you can continue taking your standard medication for FSGS while participating in the trial.

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

Research has shown that BI 764198 has been generally well tolerated in past studies. These studies tested both single and multiple doses, and participants did not experience major issues. The research demonstrated that the medicine was safe at different doses, including up to 80 mg.

In these earlier studies, BI 764198 did not cause serious side effects. The medicine targets a specific protein related to kidney problems, aiming to improve kidney health without causing harm.

Overall, existing evidence suggests that BI 764198 is safe for use. Prospective trial participants can feel reassured by these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for FSGS?

Unlike the standard treatments for Focal Segmental Glomerulosclerosis, which often include corticosteroids and immunosuppressants, BI 764198 is unique because it targets a different pathway. This drug works by inhibiting the TRPC5 ion channel, which is thought to play a role in kidney damage associated with this condition. Researchers are excited about BI 764198 because it offers a novel mechanism of action, potentially providing a new therapeutic option for patients who do not respond well to existing therapies. This new approach could lead to more effective management of the disease with potentially fewer side effects.

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

Research has shown that BI 764198, which participants in this trial may receive, might help treat focal segmental glomerulosclerosis (FSGS), a kidney condition, by targeting a protein called TRPC6, crucial for kidney cell function. This treatment improves the health and survival of podocytes, key cells in the kidneys. Studies have found that BI 764198 is well tolerated and may enhance kidney health by protecting these cells. Early results suggest it could slow kidney damage in FSGS. Although more research is needed, current findings offer promise for those with this kidney condition. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults and adolescents over 12 years old with a kidney condition called FSGS. They must have a certain level of kidney function, protein in their urine, weigh at least 40 kg, and have a BMI of ≤40 kg/m². It's open to those with biopsy-confirmed primary FSGS or genetic FSGS due to a specific gene mutation.

Inclusion Criteria

I have been diagnosed with FSGS either through a biopsy or a genetic test showing a TRPC6 mutation.

My BMI is 40 or less.

I am 12 years old or older and have given my consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take BI 764198 or placebo tablets once a day for up to 2 years, with regular health checks and urine sample collection

104 weeks

Visits every 3 months

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 BI 764198 against placebo tablets in people with FSGS. Participants are randomly assigned to one group or the other and take the tablet daily for up to two years while continuing standard treatments. The study tracks kidney health through regular urine samples and check-ups every three months.

How Is the Trial Designed?

Group I: Placebo treatment Experimental Treatment 1 Intervention

Group II: BI 764198 treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

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

TRPC6 Inhibitor BI 764198 in Focal Segmental ... 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 ...

2. 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.

3. tandfonline.com tandfonline.com/doi/full/10.1080/13543784.2025.2510664?src=

A randomized, Phase I study of the safety, tolerability, and ... Focal segmental glomerulosclerosis (FSGS) is a leading glomerular cause of chronic kidney disease (CKD) and progression to end-stage kidney disease [Citation1], ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05213624/a-study-to-test-bi-764198-in-people-with-a-type-of-kidney-disease-called-focal-segmental-glomerulosclerosis

A Study to Test BI 764198 in People With a Type of Kidney ... 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.

5. asn-online.org asn-online.org/education/kidneyweek/2022/program-abstract.aspx?controlId=3789790

Kidney Week BI 764198 is a novel, selective, oral TRPC6 inhibitor that has been shown to be well tolerated in completed Phase I studies.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40402558/

A randomized, Phase I study of the safety, tolerability, and ... Conclusions: BI 764198 was well tolerated; exposure increased near dose proportionally to 80 mg, as previously observed in predominantly White volunteers.

7. kidneyresearchnetwork.org kidneyresearchnetwork.org/fsgs-trpc6-trial

FSGS TRPC6 Trial The study is testing different doses of BI 764198 for safety, effectiveness, and side effects in patients with FSGS. ... Focal Segmental Glomerulosclerosis - Full ...