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BI 764198 for Focal Segmental Glomerulosclerosis (FSGS)

This study is looking for adults and adolescents (age 12 and older) with focal segmental glomerulosclerosis (FSGS), a kidney condition. The goal is to see if a medicine called BI 764198 can help people with FSGS. Participants will be randomly assigned to one of two groups: one group will receive BI 764198 tablets, and the other will receive a placebo (a tablet that looks the same but contains no medicine). All participants will continue their usual FSGS medications. The study will measure changes in protein levels in your urine (UPCR) over 104 weeks (about 2 years) to see if the treatment is effective. The study is planning to enroll 286 participants, but its current status is unclear.

Study design
This is an interventional study where participants are randomly assigned to receive either BI 764198 or a placebo. The study aims to enroll 286 participants.
What's involved
You would take a tablet once a day for up to 2 years and visit the study site about every 3 months during that time.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 104, which is about 2 years after starting the study.

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NCT07220083

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)

Recruiting
PHASE3Ages 12+InterventionalTreatment
Boehringer Ingelheim
~286 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:BI 764198Placebo

At a glance

Recruiting sites
185 of 306 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in 24-hour UPCR (measured in mg/g) from baseline to Week 104
Measured over Baseline and Week 104

Conditions

Focal Segmental Glomerulosclerosis

Explore related trials

Focal Segmental Glomerulosclerosis

Where it's being run

306 sites across 71 states
China22
India20
Japan19
California13
Turkey (Türkiye)11
Portugal10
France9
Taiwan9

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
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Eligibility criteria

Inclusion

Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test) 5. Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1) 6. Estimated glomerular filtration rate (eGFR)
For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)

What this trial measures

  • Relative change in 24-hour UPCR (measured in mg/g) from baseline to Week 104Baseline and Week 104

    24-hour urinary protein-to-creatinine ratio (24-hr UPCR)