Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new medication to see if it can improve kidney function in patients with primary focal segmental glomerulosclerosis (FSGS). Participants will be randomly assigned to one of four groups, three of which will receive different doses of the medication and one of which will receive a placebo. The trial will last for four months, during which participants will take the medication or placebo once daily. Kidney function will be monitored via urine samples, and general health will be monitored via regular checkups.
Eligible Conditions
- Kidney Diseases
- Chronic Kidney Disease (CKD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: up to 13 weeks
up to 12 weeks
Change in 24-hour urinary protein excretion relative to screening at week 12
Change in UPCR relative to baseline (visit 3) at weeks 4, 8, and 12
If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12
Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline (visit 3) at week 12
up to 13 weeks
Change in UPCR relative to screening at week 13
up to 4 weeks
If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
BI 764198 - medium dose
1 of 4
BI 764198 - high dose
1 of 4
BI 764198 - low dose
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group
60 Total Participants · 4 Treatment Groups
Primary Treatment: BI 764198 · Has Placebo Group · Phase 2
BI 764198 - medium dose
Drug
Experimental Group · 1 Intervention: BI 764198 · Intervention Types: DrugBI 764198 - high dose
Drug
Experimental Group · 1 Intervention: BI 764198 · Intervention Types: DrugBI 764198 - low dose
Drug
Experimental Group · 1 Intervention: BI 764198 · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 764198
2019
Completed Phase 1
~200
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 13 weeks
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,376 Previous Clinical Trials
9,766,140 Total Patients Enrolled
17 Trials studying Kidney Diseases
42,559 Patients Enrolled for Kidney Diseases
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:UPCR ≥ 1500 mg/g based on two 24-hour urine samples collected at least 7 days apart at screening.
Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
You are 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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