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

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

Phase 3 Interventional Boehringer Ingelheim · NCT07220083

This study will test BI 764198 tablets taken once daily for up to two years in adults and adolescents with FSGS to see if it lowers urine protein and preserves kidney function.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment286 (estimated)
Ages12 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsrituximab, obinutuzumab, cyclophosphamide
Locations256 sites (Alabaster, Alabama and 255 other locations)
Trial IDNCT07220083 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adolescents (≥12 years) and adults with biopsy-confirmed primary FSGS or TRPC6 gain-of-function genetic FSGS who weigh ≥40 kg, have BMI ≤40 kg/m², very high proteinuria (UPCR ≥1500 mg/g), and adequate kidney function (eGFR ≥25 mL/min/1.73 m² for adults).

Not a fit: People with low proteinuria, advanced kidney failure below the study eGFR threshold, secondary causes of FSGS, or those who cannot meet the age/weight/BMI criteria are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, BI 764198 could reduce proteinuria and slow loss of kidney function in people with FSGS.

How similar studies have performed: Targeted therapies for FSGS remain largely unproven and this Phase 3 represents one of the larger randomized tests of this specific therapy, so prior clinical success in FSGS is limited.

Eligibility criteria

Show full inclusion / exclusion 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 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 combined serum creatinine plus 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 height and 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 maladaptive 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 this trial is running

Alabaster, Alabama and 255 other locations

+206 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Focal Segmental Glomerulosclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.