Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Exclusion Criteria

• •FSGS secondary to another condition
• •Positive serological tests of another primary or secondary glomerular disease not consistent with a diagnosis of primary or genetic FSGS
• •History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, or nonfasting blood glucose \>180 mg/dL (10.0 mmol/L)
• •Treated with rituximab, cyclophosphamide, or abatacept within ≤3 months prior to screening; if taking other chronic immunosuppressive medications, the dosage must be stable prior to screening
• •Documented history of heart failure, coronary artery disease, or cerebrovascular disease
• •Significant liver disease
• •Positive at screening for the human immunodeficiency virus or markers indicating acute or chronic hepatitis B virus infection or hepatitis C infection
• •History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
• •Screening hematocrit value \<27% (0.27 L/L) or hemoglobin value \<9 g/dL (90 g/L)
• •Screening potassium value of \>5.5 mEq/L (5.5 mmol/L)
• •Extreme obesity (ie, ≥18 years of age with a body mass index (BMI) \>40, or is \<18 years of age with a BMI in the 99th percentile plus 5 units at screening, in whom there is a causal relationship between obesity and the development of FSGS
• •History of alcohol or illicit drug use disorder
• •History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist
• •Female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
• •Progression to end-stage renal disease requiring replacement therapy
• •The patient developed criteria for discontinuation between Week 108 and Week 112
• •The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 108 and Week 112
• •eGFR ≤20 mL/min/1.73 m2 at Week 108