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Status:

NOT_YET_RECRUITING

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Focal Segmental Glomerulosclerosis

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

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 help...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
  • Weight of ≥40 kg at the screening visit (Visit 1)
  • Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
  • 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)
  • 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)
  • 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:
  • Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
  • Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator's judgement)
  • FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
  • A history of organ transplantation or planned organ transplantation during the course of the trial
  • Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.

Exclusion

    Key Trial Info

    Start Date :

    January 23 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 18 2029

    Estimated Enrollment :

    286 Patients enrolled

    Trial Details

    Trial ID

    NCT07220083

    Start Date

    January 23 2026

    End Date

    December 18 2029

    Last Update

    January 9 2026

    Active Locations (187)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 47 (187 locations)

    1

    Alabama Kidney Research

    Alabaster, Alabama, United States, 35007

    2

    Nephrology Consultants, LLC

    Huntsville, Alabama, United States, 35805

    3

    Amicis Research Center - Balboa

    Granada Hills, California, United States, 91344

    4

    Academic Medical Research Institute - Glendale

    Los Angeles, California, United States, 90022