Last updated on August 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Focal glomerulosclerosis
  • Age: Between 8 - 75 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • Sites within the US: The patient is male or female aged 8 to 75 years, inclusive, weighing 20 kg at screening
  • Sites outside the US: The patient is male or female aged 18 to 75 years, inclusive, weighing 20 kg at screening
  • Biopsy-proven focal segmental glomerulosclerosis (FSGS) or documentation of a genetic mutation in a podocyte protein associated with FSGS
  • Urine protein/creatinine (UP/C) 1.5 g/g at screening
  • eGFR 30 mL/min/1.73 m2 at screening.
  • Women of childbearing potential (WOCBP) must agree to the use of one highly reliable method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication, plus one additional barrier method during sexual activity

Key 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
  • 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 (HIV) or markers indicating acute or chronic hepatitis B 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% or hemoglobin value <9 g/dL
  • Screening potassium value of >5.5 mEq/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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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