BI 764198 for adults and adolescents with focal segmental glomerulosclerosis (FSGS).

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 3 study assigns participants by chance to take either BI 764198 or a matching placebo once daily while they continue their standard FSGS medicines. Participants are treated and followed for up to two years with clinic visits about every three months and regular urine collections to track proteinuria and kidney function. The trial compares changes in urine protein and renal function between the two groups and includes routine safety monitoring. Central laboratories are used for key measurements such as urine protein-creatinine ratio.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alabama Kidney Research
  Alabaster, Alabama, United States Recruiting
• Apogee Clinical Research
  Huntsville, Alabama, United States Recruiting
• Southwest Kidney Institute
  Surprise, Arizona, United States Recruiting
• West Coast Kidney Institute
  Fremont, California, United States Recruiting
• Kidney Disease Medical Group
  Glendale, California, United States Recruiting
• Amicis Research Center - Balboa
  Granada Hills, California, United States Recruiting

+265 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Praliciguat treatment for adults with focal segmental glomerulosclerosis (FSGS)

  This will test if praliciguat lowers urine protein in adults with biopsy-confirmed FSGS.

  Recruiting at 31 sites Phase 2 Akebia Therapeutics · Chula Vista, California and 31 other locations · NCT07268638

• Testing ManNAc for treating kidney disease FSGS

  This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06664814

• Evaluating treatments for kidney diseases in young to middle-aged adults

  This study is testing three different treatments for kidney diseases in young to middle-aged adults to see if they can reduce protein levels in urine and help with symptoms over 24 weeks.

  Recruiting at 78 sites Phase 2 Sanofi · Birmingham, Alabama and 78 other locations · NCT06500702

• Registry and biobank for resistant nephrotic syndrome treatment responses

  This study is collecting information from patients with resistant nephrotic syndrome to see how different treatments work and to help find better options for the future.

  Recruiting Medical University of Vienna · Vienna · NCT06162546

• Using Metformin to Improve Kidney Health in FSGS

  This study is testing if taking extended-release Metformin along with regular treatment can help improve kidney health in people with Focal Segmental Glomerulosclerosis (FSGS).

  Recruiting at 2 sites Phase 1/2 Yale University · New Haven, Connecticut and 1 other locations · NCT06090227

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.