NIPH Clinical Trials Search

A study to find out if BI 764198 helps adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	primary focal segmental glomerulosclerosis (pFSGS)
Date of first enrollment	30/04/2026
Target sample size	20
Countries of recruitment	United States,Japan,Europe,Japan,Asia,Japan
Study type	Interventional
Intervention(s)	Experimental: BI 764198 treatment Drug: BI 764198 BI 764198 Experimental: Placebo treatment Drug: Placebo Placebo matching BI 764198

Outcome(s)

Primary Outcome

Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104

Secondary Outcome

Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104 Treatment response, defined as 24-hr UPCR less than1000 mg/g at Week 104 Treatment response, defined as 24-hr UPCR less than 1000 mg/g and eGFRcys at least 85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint) Complete remission, defined as 24-hr UPCR less than 300 mg/g at Week 104 Change from baseline across disease-specific clinical outcome assessment (COA) NS-SIM-PRO at Week 104 Change from baseline across clinical outcome assessment (COA) KDQOL-36 at Week 104

Key inclusion & exclusion criteria

Age minimum	>= 12age old
Age maximum	Not applicable
Gender	Both
Include criteria	Male or female participants at least 12 years old on the day of signing informed consent/assent (Visit 1) Weight of at least 40 kg at the screening visit (Visit 1) Body mass index (BMI) of less than 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) at least 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 (at least 18 years): at least 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 at least 18 years): at least 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.
Exclude 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 Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.