DUET

Clinical Trial of Sparsentan

Study overview

FSGS causes loss of protein in the urine, high lipids in blood, and other complications. This study is being done to collect information about the possible effects of a new medication called RE-021 on urine protein loss in patients with FSGS, as well as other positive and negative effects of the treatment. RE-021 has not been approved by the US Food and Drug Administration for the treatment of FSGS. This study involves being randomly chosen to take either RE-021, or a medicine already used to treat FSGS called irbesartan. You will have a 75% chance of receiving RE-021 and a 25% chance of receiving irbesartan. Neither you nor the doctors will know which treatment you are taking. After 8 weeks, all patients in the study will then receive RE-021 for about 40 weeks, even if they were previously assigned to take irbesartan.

Eligibility Criteria

You MIGHT be eligible to participate if you:

  • Are between the ages of 8 and 65
  • Have had a kidney biopsy confirming FSGS
  • Have proteinuria
  • Have not had any changes to your medication dosages within the past month.
  • Have an estimated GFR >30ml/min

    You CANNOT participate if you:

  • Have taken Rituximab or cyclophosphamide within the past 3 months
  • Have had an organ transplant
  • Are Pregnant or Breastfeeding
  • Have a history of Cancer (other than skin cancer)
  • Have a history of heart problems including heart attack
  • Have type 1 or type 2 diabetes mellitus
  • Have a BMI >40

    how to get involved

    For more information or to participate, please contact:

    Emily Herreshoff, CCRP
    Phone: (734) 232-4852
    Email: egalopin@umich.edu

    www.fsgsduetstudy.com