A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Boehringer Ingelheim · NCT07220083
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 286
- US sites recruiting
- 56
- Study start
- February 16, 2026
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: BI 764198; Placebo
Conditions: Focal Segmental Glomerulosclerosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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 (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.
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 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.
Recruiting US locations
Alabama Kidney Research
Alabaster, AL 35007
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Apogee Clinical Research
Huntsville, AL 35805
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Southwest Kidney Institute
Surprise, AZ 85374-4840
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
West Coast Kidney Institute
Fremont, CA 94538
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Kidney Disease Medical Group
Glendale, CA 91206
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Amicis Research Center - Balboa
Granada Hills, CA 91344
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Valiance Clinical Research
Huntington Park, CA 90255
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Academic Medical Research Institute - Glendale
Los Angeles, CA 90022
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, CA 90027
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Shasta Critical Care Specialists
Redding, CA 96001
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
North America Research Institute
San Dimas, CA 91773
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Kaiser Permanente - French Campus
San Francisco, CA 94118
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Valiance Clinical Research-Tarzana-68237
Tarzana, CA 91356
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
National Institute of Clinical Research - Victorville
Victorville, CA 92392
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Kidney Associates of Colorado - Denver
Denver, CO 80210
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Colorado Kidney Care
Denver, CO 80220
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Florida Kidney Physicians - Boca Raton
Boca Raton, FL 33487
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Florida Kidney Physicians, LLC - Fort Lauderdale
Fort Lauderdale, FL 33316
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Total Research Group, LLC
Miami, FL 33126
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
CTR Oakwater, LLC
Orlando, FL 32806
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Florida Kidney Physicians - Riverview/Brandon
Riverview, FL 33578
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Coastal Medical Research, LLC
Brunswick, GA 31520
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Southeast Kidney Associates - East Point
East Point, GA 30344
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Memorial Health University Hospital
Savannah, GA 31404
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Kidney Care Center - Olympia Fields
Olympia Fields, IL 60461
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
EmVenio Research Inc. - Kansas City
Kansas City, KS 66112
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Wichita Nephrology Group
Wichita, KS 67214
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Renal Associates of Baton Rouge
Baton Rouge, LA 70808
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Northwest Louisiana Nephrology
Shreveport, LA 71101
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Johns Hopkins Hospital
Baltimore, MD 21287
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Henry Ford Hospital
Detroit, MI 48202
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Paragon Health Nephrology Center - Kalamazoo
Kalamazoo, MI 49007
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
St. Clair Nephrology Research, LLC - Shelby Township
Utica, MI 48315
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Nephrology Associates - Columbus
Columbus, MS 39705
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Nephrology & Hypertension Associates, Ltd.
Tupelo, MS 38801
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Elixia MNA, LLC
City of Saint Peters, MO 63376
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
DaVita Clinical Research-Las Vegas-67781
Las Vegas, NV 89107
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
New York Nephrology and Dialysis Access Surgery, PC
Clifton Park, NY 12065
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
NYU Langone Nephrology Associates-Mineola
Mineola, NY 11501
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Carolina Kidney Associates
Greensboro, NC 27405-3654
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cardinal Clinical Research, LLC - Shelby
Shelby, NC 28150
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Americare Kidney Institute - Brunswick
Brunswick, OH 44212
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
The Kidney and Hypertension Center
Cincinnati, OH 45212
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cincinnati Children's Hospital Medical Center
Cincinnati, OH 45229
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
The Ohio State University Wexner Medical Center
Columbus, OH 43210
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clinical Renal Associates
Exton, PA 19341
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Nephrology Associates, Inc
East Providence, RI 02914-2641
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Southeast Renal Research Institute
Chattanooga, TN 37404
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Texas Tech University Health Sciences Center-Amarillo-63885
Amarillo, TX 79106
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
The Healing Kidneys Institute
Conroe, TX 77304
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Provecta Researh Network
Houston, TX 77027
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Provecta Research Path Forward Ventures
Humble, TX 77338
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Utah Kidney Research Institute
Salt Lake City, UT 84115
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Virginia Nephrology
Arlington, VA 22205
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Nephrology Associates of Northern Virginia
Fairfax, VA 22150
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Virginia Commonwealth University
Richmond, VA 23298
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Study contacts (from the official record)
- Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com