Recruiting
Phase 3

BI 764198

Sponsor:

Boehringer Ingelheim

Code:

NCT07220083

Conditions

Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

BI 764198

Placebo

Study Details

Brief 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.

Conditions

Focal Segmental Glomerulosclerosis

Study ID

NCT07220083

Start date

Feb 16, 2026

Status verified date

Aug, 2026

Completion date

Jan 24, 2029

Anticipated

Primary completion date

Dec 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

286 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BI 764198 treatment

experimental: Placebo treatment

Interventions

BI 764198

BI 764198

Placebo

Placebo matching BI 764198

Primary outcome measure

  • Relative change in 24-hour UPCR (measured in mg/g) from baseline to Week 104 [ Time Frame: Baseline and Week 104 ]

Central Contacts and Locations

Central contacts

Locations

Alabama Kidney Research

Recruiting

Alabaster, Alabama, United States, 35007

Contacts

Apogee Clinical Research

Recruiting

Huntsville, Alabama, United States, 35805

Contacts

Southwest Kidney Institute

Recruiting

Surprise, Arizona, United States, 85374-4840

Contacts

West Coast Kidney Institute

Recruiting

Fremont, California, United States, 94538

Contacts

Kidney Disease Medical Group

Recruiting

Glendale, California, United States, 91206

Contacts

Amicis Research Center - Balboa

Recruiting

Granada Hills, California, United States, 91344

Contacts

Valiance Clinical Research

Recruiting

Huntington Park, California, United States, 90255

Contacts

Academic Medical Research Institute - Glendale

Recruiting

Los Angeles, California, United States, 90022

Contacts

North America Research Institute

Recruiting

San Dimas, California, United States, 91773

Contacts

Valiance Clinical Research-Tarzana-68237

Recruiting

Tarzana, California, United States, 91356

Contacts

National Institute of Clinical Research - Victorville

Recruiting

Victorville, California, United States, 92392

Contacts

Kidney Associates of Colorado - Denver

Recruiting

Denver, Colorado, United States, 80210

Contacts

Colorado Kidney Care

Recruiting

Denver, Colorado, United States, 80220

Contacts

Florida Kidney Physicians - Boca Raton

Recruiting

Boca Raton, Florida, United States, 33487

Contacts

Florida Kidney Physicians, LLC - Fort Lauderdale

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Total Research Group, LLC

Recruiting

Miami, Florida, United States, 33126

Contacts

CTR Oakwater, LLC

Recruiting

Orlando, Florida, United States, 32806

Contacts

Florida Kidney Physicians - Riverview/Brandon

Recruiting

Riverview, Florida, United States, 33578

Contacts

Southeast Kidney Associates - East Point

Recruiting

East Point, Georgia, United States, 30344

Contacts

Memorial Health University Hospital

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Wichita Nephrology Group

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Northwest Louisiana Nephrology

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

St. Clair Nephrology Research, LLC - Shelby Township

Recruiting

Utica, Michigan, United States, 48315

Contacts

Elixia MNA, LLC

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

DaVita Clinical Research-Las Vegas-67781

Recruiting

Las Vegas, Nevada, United States, 89107

Contacts

New York Nephrology and Dialysis Access Surgery, PC

Recruiting

Clifton Park, New York, United States, 12065

Contacts

Cardinal Clinical Research, LLC - Shelby

Recruiting

Shelby, North Carolina, United States, 28150

Contacts

The Kidney and Hypertension Center

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

Clinical Renal Associates

Recruiting

Exton, Pennsylvania, United States, 19341

Contacts

Nephrology Associates, Inc

Recruiting

East Providence, Rhode Island, United States, 02914-2641

Contacts

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Provecta Researh Network

Recruiting

Houston, Texas, United States, 77027

Contacts

Utah Kidney Research Institute

Recruiting

Salt Lake City, Utah, United States, 84115

Contacts

Virginia Nephrology

Recruiting

Arlington, Virginia, United States, 22205

Contacts

Nephrology Associates of Northern Virginia

Recruiting

Fairfax, Virginia, United States, 22150

Contacts

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Victoria Hospital (LHSC)

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-20.