Status:
NOT_YET_RECRUITING
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 help...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- Weight of ≥40 kg at the screening visit (Visit 1)
- Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
- Participants with a diagnosis prior to the screening visit (Visit 1) of either:
- 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)
- Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
- 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 combined serum creatinine plus cystatin C) at the screening visit (Visit 1)
- For adolescent participants (12 to \<18 years); ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using height and serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.
- Exclusion criteria:
- Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator's judgement)
- FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
- A history of organ transplantation or planned organ transplantation during the course of the trial
- Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
January 23 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2029
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT07220083
Start Date
January 23 2026
End Date
December 18 2029
Last Update
January 9 2026
Active Locations (187)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Kidney Research
Alabaster, Alabama, United States, 35007
2
Nephrology Consultants, LLC
Huntsville, Alabama, United States, 35805
3
Amicis Research Center - Balboa
Granada Hills, California, United States, 91344
4
Academic Medical Research Institute - Glendale
Los Angeles, California, United States, 90022