Home › Focal Segmental Glomerulosclerosis › NCT07220083
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
RecruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants
Who can join
Ages 12 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- BI 764198 (drug)
- Placebo (drug)
Sponsor: Boehringer Ingelheim · Participants: 286 · Started: Feb 16, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07220083
Locations in the U.S.
| Alabama | Alabama Kidney Research, Alabaster Apogee Clinical Research, Huntsville |
| California | West Coast Kidney Institute, Fremont Kidney Disease Medical Group, Glendale Valiance Clinical Research, Huntington Park Academic Medical Research Institute - Glendale, Los Angeles Kaiser Permanente - Los Angeles Medical Center, Los Angeles University of California Los Angeles, Los Angeles (Not yet recruiting) Valley Renal Medical Group - Northridge, Northridge (Not yet recruiting) Shasta Critical Care Specialists, Redding North America Research Institute, San Dimas Kaiser Permanente - French Campus, San Francisco (Not yet recruiting) Valiance Clinical Research-Tarzana-68237, Tarzana |
| Colorado | Colorado Kidney Care, Denver Kidney Associates of Colorado - Denver, Denver |
| District of Columbia | George Washington University Medical Faculty Associates, Washington D.C. (Not yet recruiting) |
| Florida | Florida Kidney Physicians - Boca Raton, Boca Raton Florida Kidney Physicians, LLC - Fort Lauderdale, Fort Lauderdale Total Research Group, LLC, Miami CTR Oakwater, LLC, Orlando Coastal Nephrology and Associates, Port Charlotte (Not yet recruiting) Florida Kidney Physicians - Riverview/Brandon, Riverview |
| Georgia | Emory Children's Center, Atlanta (Not yet recruiting) Coastal Medical Research, LLC, Brunswick Southeast Kidney Associates - East Point, East Point Memorial Health University Hospital, Savannah |
| Illinois | Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago (Not yet recruiting) Northwestern University, Chicago (Not yet recruiting) Endeavor Health, Evanston (Not yet recruiting) Kidney Care Center - Olympia Fields, Olympia Fields (Not yet recruiting) |
| Indiana | Nephrology Physicians - Mishawaka, Mishawaka (Not yet recruiting) |
| Kansas | EmVenio Research Inc. - Kansas City, Kansas City (Not yet recruiting) Wichita Nephrology Group, Wichita |
| Louisiana | Renal Associates of Baton Rouge, Baton Rouge Northwest Louisiana Nephrology, Shreveport |
| Maryland | Johns Hopkins Hospital, Baltimore (Not yet recruiting) |
| Massachusetts | Joslin Diabetes Center, Boston (Not yet recruiting) |
| Michigan | Henry Ford Hospital, Detroit (Not yet recruiting) Paragon Health Nephrology Center - Kalamazoo, Kalamazoo (Not yet recruiting) St. Clair Nephrology Research, LLC - Shelby Township, Utica |
| Mississippi | Nephrology Associates - Columbus, Columbus Nephrology & Hypertension Associates, Ltd., Tupelo (Not yet recruiting) |
| Missouri | Elixia MNA, LLC, City of Saint Peters |
| Nevada | DaVita Clinical Research-Las Vegas-67781, Las Vegas |
| New York | New York Nephrology and Dialysis Access Surgery, PC, Clifton Park NYU Langone Nephrology Associates-Mineola, Mineola |
| North Carolina | Duke University Medical Center, Durham (Not yet recruiting) Carolina Kidney Associates, Greensboro (Not yet recruiting) Cardinal Clinical Research, LLC - Shelby, Shelby |
| Ohio | Americare Kidney Institute - Brunswick, Brunswick (Not yet recruiting) Cincinnati Children's Hospital Medical Center, Cincinnati The Kidney and Hypertension Center, Cincinnati Nationwide Children's Hospital, Columbus (Not yet recruiting) The Ohio State University Wexner Medical Center, Columbus (Not yet recruiting) |
| Pennsylvania | Northeast Clinical Research Center, Bethlehem (Not yet recruiting) University of Pennsylvania, Philadelphia (Not yet recruiting) |
| Rhode Island | Nephrology Associates, Inc, East Providence |
| South Carolina | Palmetto Nephrology, Orangeburg (Not yet recruiting) |
| Tennessee | Southeast Renal Research Institute, Chattanooga |
| Texas | Texas Tech University Health Sciences Center-Amarillo-63885, Amarillo (Not yet recruiting) The Healing Kidneys Institute, Conroe (Not yet recruiting) Advanced Dallas Hospital and Clinics, Dallas (Not yet recruiting) Nephrotex Research Group, Dallas (Not yet recruiting) University of Texas Medical Branch at Galveston, Galveston (Not yet recruiting) Provecta Researh Network, Houston Provecta Research Path Forward Ventures, Humble |
| Utah | Primary Children's Hospital, Salt Lake City (Not yet recruiting) Utah Kidney Research Institute, Salt Lake City |
| Virginia | Nephrology Associates of Northern Virginia, Fairfax Virginia Commonwealth University, Richmond |
| West Virginia | West Virginia University Medicine, Morgantown (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.