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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Focal Segmental Glomerulosclerosis

In brief

PODOMOUNT-pFSGS 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 helps people with FSGS. Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS. Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Key facts

Study ID

NCT07220083

Run by

Boehringer Ingelheim

People needed

286

Starts

2026-02-16

Expected to finish

2029-01-24

Last updated by the study team

2026-08-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (FMV) 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 serum 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 serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.

You may not qualify if…

• Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
• Clinical or histologic evidence of secondary adaptive 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.

Where it is running

• St. Clair Nephrology Research, LLC - Shelby Township — Utica, Michigan, United States (enrolling)
• Cardinal Clinical Research, LLC - Shelby — Shelby, North Carolina, United States (enrolling)
• Wichita Nephrology Group — Wichita, Kansas, United States (enrolling)
• Northwest Louisiana Nephrology — Shreveport, Louisiana, United States (enrolling)
• DaVita Clinical Research-Las Vegas-67781 — Las Vegas, Nevada, United States (enrolling)
• New York Nephrology and Dialysis Access Surgery, PC — Clifton Park, New York, United States (enrolling)
• Apogee Clinical Research — Huntsville, Alabama, United States (enrolling)
• Southeast Kidney Associates - East Point — East Point, Georgia, United States (enrolling)
• Kidney Disease Medical Group — Glendale, California, United States (enrolling)
• Alabama Kidney Research — Alabaster, Alabama, United States (enrolling)
• Southwest Kidney Institute — Surprise, Arizona, United States (enrolling)
• North America Research Institute — San Dimas, California, United States (enrolling)
• Valiance Clinical Research — Huntington Park, California, United States (enrolling)
• Valiance Clinical Research-Tarzana-68237 — Tarzana, California, United States (enrolling)
• National Institute of Clinical Research - Victorville — Victorville, California, United States (enrolling)
• Academic Medical Research Institute - Glendale — Los Angeles, California, United States (enrolling)
• Colorado Kidney Care — Denver, Colorado, United States (enrolling)
• West Coast Kidney Institute — Fremont, California, United States (enrolling)
• Florida Kidney Physicians - Boca Raton — Boca Raton, Florida, United States (enrolling)
• Florida Kidney Physicians, LLC - Fort Lauderdale — Fort Lauderdale, Florida, United States (enrolling)
• Total Research Group, LLC — Miami, Florida, United States (enrolling)
• CTR Oakwater, LLC — Orlando, Florida, United States (enrolling)
• Florida Kidney Physicians - Riverview/Brandon — Riverview, Florida, United States (enrolling)
• Amicis Research Center - Balboa — Granada Hills, California, United States (enrolling)
• The Kidney and Hypertension Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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