67 Participants Needed

BI 764198 for Focal Segmental Glomerulosclerosis

Recruiting at 70 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Boehringer Ingelheim
Must be taking: Corticosteroids, ACE inhibitors
Prior Safety DataThis treatment has passed at least one previous human trial

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
4Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 764198 - medium doseExperimental Treatment1 Intervention
BI 764198 - medium dose
Group II: BI 764198 - low doseExperimental Treatment1 Intervention
BI 764198 - low dose
Group III: BI 764198 - high doseExperimental Treatment1 Intervention
BI 764198 - high dose
Group IV: PlaceboPlacebo Group1 Intervention
Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security