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
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.
How Is the Trial Designed?
BI 764198 - medium dose
BI 764198 - low dose
BI 764198 - high dose
Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Citations
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 ...
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.
A randomized, Phase I study of the safety, tolerability, and ...
BI 764198 is a selective, oral transient receptor potential cation channel, subfamily C, member 6 inhibitor under investigation for focal segmental ...
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.
Kidney Week
The efficacy, safety, pharmacokinetic (PK) and pharmacodynamic profiles of BI 764198 are being assessed for the first time in patients with primary FSGS or ...
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.
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 ...
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