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


About this study

The purpose of this study is to determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 m^2 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.

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 (i.e., ≥ 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Open for enrollment

Contact information:

Jessica O'Neill

(507) 266-1047

More information


Publications are currently not available

Study Results Summary

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Supplemental Study Information

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