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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

Sponsor: Boehringer Ingelheim · Participants: 286 · Started: Feb 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07220083

Locations in the U.S.

AlabamaAlabama Kidney Research, Alabaster
Apogee Clinical Research, Huntsville
CaliforniaWest 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
ColoradoColorado Kidney Care, Denver
Kidney Associates of Colorado - Denver, Denver
District of ColumbiaGeorge Washington University Medical Faculty Associates, Washington D.C. (Not yet recruiting)
FloridaFlorida 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
GeorgiaEmory Children's Center, Atlanta (Not yet recruiting)
Coastal Medical Research, LLC, Brunswick
Southeast Kidney Associates - East Point, East Point
Memorial Health University Hospital, Savannah
IllinoisAnn & 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)
IndianaNephrology Physicians - Mishawaka, Mishawaka (Not yet recruiting)
KansasEmVenio Research Inc. - Kansas City, Kansas City (Not yet recruiting)
Wichita Nephrology Group, Wichita
LouisianaRenal Associates of Baton Rouge, Baton Rouge
Northwest Louisiana Nephrology, Shreveport
MarylandJohns Hopkins Hospital, Baltimore (Not yet recruiting)
MassachusettsJoslin Diabetes Center, Boston (Not yet recruiting)
MichiganHenry Ford Hospital, Detroit (Not yet recruiting)
Paragon Health Nephrology Center - Kalamazoo, Kalamazoo (Not yet recruiting)
St. Clair Nephrology Research, LLC - Shelby Township, Utica
MississippiNephrology Associates - Columbus, Columbus
Nephrology & Hypertension Associates, Ltd., Tupelo (Not yet recruiting)
MissouriElixia MNA, LLC, City of Saint Peters
NevadaDaVita Clinical Research-Las Vegas-67781, Las Vegas
New YorkNew York Nephrology and Dialysis Access Surgery, PC, Clifton Park
NYU Langone Nephrology Associates-Mineola, Mineola
North CarolinaDuke University Medical Center, Durham (Not yet recruiting)
Carolina Kidney Associates, Greensboro (Not yet recruiting)
Cardinal Clinical Research, LLC - Shelby, Shelby
OhioAmericare 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)
PennsylvaniaNortheast Clinical Research Center, Bethlehem (Not yet recruiting)
University of Pennsylvania, Philadelphia (Not yet recruiting)
Rhode IslandNephrology Associates, Inc, East Providence
South CarolinaPalmetto Nephrology, Orangeburg (Not yet recruiting)
TennesseeSoutheast Renal Research Institute, Chattanooga
TexasTexas 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
UtahPrimary Children's Hospital, Salt Lake City (Not yet recruiting)
Utah Kidney Research Institute, Salt Lake City
VirginiaNephrology Associates of Northern Virginia, Fairfax
Virginia Commonwealth University, Richmond
West VirginiaWest 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.