BI 764198 for Focal Segmental Glomerulosclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, BI 764198, to determine if it can improve kidney health in people with focal segmental glomerulosclerosis (FSGS), a type of kidney disease. Participants will be randomly assigned to one of four groups, receiving either a low, medium, or high dose of BI 764198 or a placebo (a pill with no medicine). Suitable candidates for this trial are adults diagnosed with FSGS through a kidney biopsy or a specific gene mutation and who have high protein levels in their urine. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in kidney disease treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BI 764198, a medicine tested for kidney disease, was generally well tolerated in earlier studies. These studies found that people could take different doses without major issues. Even at higher doses, participants did not experience significant side effects. This suggests that BI 764198 might be safe for humans. However, since the current study remains in the middle stages, researchers must continue to monitor its safety and effectiveness with more participants.12345
Why do researchers think this study treatment might be promising for FSGS?
Researchers are excited about BI 764198 for Focal Segmental Glomerulosclerosis (FSGS) because it offers a new approach compared to standard treatments like corticosteroids and immunosuppressants. Unlike these traditional therapies, which often come with significant side effects and varying efficacy, BI 764198 targets a specific pathway involved in kidney inflammation and damage. This precision could lead to better outcomes with fewer side effects. Furthermore, BI 764198 is being tested in varying doses (low, medium, and high), allowing researchers to determine the most effective and safest dosage, potentially leading to a more personalized treatment approach for patients with FSGS.
What evidence suggests that BI 764198 might be an effective treatment for FSGS?
Research has shown that BI 764198 blocks a specific protein in kidney cells called TRPC6. By inhibiting this protein, the medicine may enhance kidney cell function and longevity. Early results suggest potential benefits for people with focal segmental glomerulosclerosis (FSGS), a type of kidney disease. In this trial, participants will receive varying doses of BI 764198 or a placebo to assess its effectiveness. The treatment aims to improve kidney health by supporting these vital cells. Although still under investigation, the medicine's mechanism offers hope for better kidney health in those with FSGS.23467
Are You a Good Fit for This Trial?
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 for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BI 764198 or placebo as capsules once a day for about 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BI 764198
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor