Focal Segmental Glomerulosclerosis Clinical Trials

• 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.