BI 764198 for Focal Segmental Glomerulosclerosis

Recruiting at 70 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Corticosteroids, ACE inhibitors

Must not be taking: Calcineurin inhibitors, Cytotoxic agents

Disqualifiers: Diabetic nephropathy, Lupus nephritis, others

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

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

67 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that if you are taking corticosteroids, ACE inhibitors, ARBs, finerenone, aldosterone inhibitors, or SGLT2 inhibitors, you must be on a stable dose for at least 4 weeks before the trial and continue without changing the dose during the trial. You cannot use calcineurin inhibitors or certain cytotoxic agents during the trial.

What is the purpose of this trial?

This trial tests if the medicine BI 764198 can improve kidney health in adults with a specific kidney disease called FSGS. Participants take the medicine regularly for a few months. Their kidney health is checked through urine samples and regular health check-ups.

Eligibility Criteria

Adults with primary focal segmental glomerulosclerosis (FSGS), a type of kidney disease, can join this study. Participants will be tested for their kidney health and must commit to multiple study visits or have a research nurse visit them at home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 764198 or placebo as capsules once a day for about 3 months

12 weeks

10 visits (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 764198
• Placebo

Trial Overview The trial is testing BI 764198, a potential new treatment for FSGS. It involves three different doses of the medication compared to a placebo, taken as capsules daily over approximately three months within the four-month study period.

Participant Groups

Group I: BI 764198 - medium dose Experimental Treatment 1 Intervention

BI 764198 - medium dose

Group II: BI 764198 - low dose Experimental Treatment 1 Intervention

BI 764198 - low dose

Group III: BI 764198 - high dose Experimental Treatment 1 Intervention

BI 764198 - high dose

Group IV: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+