Your session is about to expire
← Back to Search
Unknown
BI 764198 for Focal Segmental Glomerulosclerosis
Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
* Patients diagnosed with biopsy proven primary Focal Segmental Glomerulosclerosis (FSGS) or documented Transient Receptor Potential Cation subfamily C Member 6 (TRPC6) gene mutation causing FSGS prior to screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects are not specified here but generally could include reactions related to the digestive system, skin, blood or other organs due to medication intake. Regular health checks aim to monitor any adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 764198
2019
Completed Phase 1
~200
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Focal Segmental Glomerulosclerosis (FSGS) include corticosteroids, immunosuppressive agents, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). Corticosteroids and immunosuppressive agents work by reducing inflammation and suppressing the immune system, which helps to decrease the damage to the glomeruli.
ACE inhibitors and ARBs help to lower blood pressure and reduce proteinuria, which can slow the progression of kidney damage. The trial studying BI 764198 focuses on its potential to improve kidney health in FSGS patients, likely by targeting specific pathways involved in kidney function and inflammation.
Understanding these mechanisms is crucial for FSGS patients as it helps in selecting the most effective treatment to manage their condition and prevent further kidney damage.
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,897,228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: BI 764198 - medium dose
- Group 2: BI 764198 - high dose
- Group 3: Placebo
- Group 4: BI 764198 - low dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.