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Clinical Trials in the USA / NCT07220083
Recruiting Phase 3

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

NCT07220083 · tracked via the Priya Life Science USA tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2026-02-16
Last updated
2026-09-17

Condition(s) studied

Focal Segmental Glomerulosclerosis

Investigational drug(s) / intervention(s)

BI 764198Placebo

BI 764198: BI 764198

Placebo: Placebo matching BI 764198

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion criteria: 1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1) 2. Weight of ≥40 kg at the screening visit (Visit 1) 3. Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1) 4. 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) 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) * 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. Exclusion criteria: 1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations) 2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement) 3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement) 4. A history of organ transplantation or planned organ transplantation during the course of the trial 5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (307)

FacilityCityRegionStatus
Alabama Kidney Research Alabaster Alabama Recruiting
Apogee Clinical Research Huntsville Alabama Recruiting
Southwest Kidney Institute Surprise Arizona Suspended
West Coast Kidney Institute Fremont California Recruiting
Kidney Disease Medical Group Glendale California Recruiting
Valiance Clinical Research Huntington Park California Recruiting
Academic Medical Research Institute - Glendale Los Angeles California Recruiting
Kaiser Permanente - Los Angeles Medical Center Los Angeles California Recruiting
University of California Los Angeles Los Angeles California Not Yet Recruiting
Valley Renal Medical Group - Northridge Northridge California Not Yet Recruiting
Shasta Critical Care Specialists Redding California Recruiting
North America Research Institute San Dimas California Recruiting
Kaiser Permanente - French Campus San Francisco California Not Yet Recruiting
Valiance Clinical Research-Tarzana-68237 Tarzana California Recruiting
Kidney Associates of Colorado - Denver Denver Colorado Recruiting
Colorado Kidney Care Denver Colorado Recruiting
George Washington University Medical Faculty Associates Washington D.C. District of Columbia Not Yet Recruiting
Florida Kidney Physicians - Boca Raton Boca Raton Florida Recruiting
Florida Kidney Physicians, LLC - Fort Lauderdale Fort Lauderdale Florida Recruiting
Total Research Group, LLC Miami Florida Recruiting
CTR Oakwater, LLC Orlando Florida Recruiting
Coastal Nephrology and Associates Port Charlotte Florida Not Yet Recruiting
Florida Kidney Physicians - Riverview/Brandon Riverview Florida Recruiting
Emory Children's Center Atlanta Georgia Not Yet Recruiting
Coastal Medical Research, LLC Brunswick Georgia Recruiting
Southeast Kidney Associates - East Point East Point Georgia Recruiting
Memorial Health University Hospital Savannah Georgia Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois Not Yet Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
Endeavor Health Evanston Illinois Not Yet Recruiting
Kidney Care Center - Olympia Fields Olympia Fields Illinois Not Yet Recruiting
Nephrology Physicians - Mishawaka Mishawaka Indiana Not Yet Recruiting
EmVenio Research Inc. - Kansas City Kansas City Kansas Not Yet Recruiting
Wichita Nephrology Group Wichita Kansas Recruiting
Renal Associates of Baton Rouge Baton Rouge Louisiana Recruiting
Northwest Louisiana Nephrology Shreveport Louisiana Recruiting
Johns Hopkins Hospital Baltimore Maryland Not Yet Recruiting
Joslin Diabetes Center Boston Massachusetts Not Yet Recruiting
Henry Ford Hospital Detroit Michigan Not Yet Recruiting
Paragon Health Nephrology Center - Kalamazoo Kalamazoo Michigan Not Yet Recruiting

+ 267 more sites — see the full list on the official registry below.

More Boehringer Ingelheim trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220083 on ClinicalTrials.gov ↗ ← All trials in the USA