A Phase 2 12-Week Adaptive Open Label Sequential Cohort Trial to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of PF06730512 Following Multiple Doses in Adult Subjects with 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 Segmental Glomerulosclerosis (fsgs).
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants must provide written informed consent form
    2. Have a confirmed diagnosis of Focal Segmental Glomerulosclerosis (FSGS)
    3. Based on all previous treatment received for FSGS, participant is eligible if:
      • has been treated with at least 1, and up to 3 classes of Immunosuppressants* either alone or in combination;
      • OR has a contraindication to any class of Immunosuppressant
    4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures including completion of daily diaries to record symptoms and urine collections
    5. Female subjects of non-childbearing potential will meet at least 1 of the following criteria:
      • Achieved postmenopausal status
      • Have undergone a documented hysterectomy and/or bilateral oophorectomy
      • Have medically confirmed ovarian failure

You may not be eligible for this study if the following are true:

    1. Diagnosis of collapsing FSGS
    2. Advanced chronic changes on renal biopsy
    3. Evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or hepatic disease, like cirrhosis or chronic active liver disease.
    4. Organ transplantation
    5. History of any malignancy
    6. Body mass index (BMI) >45 kg/m2
    7. Treatment with rituximab
    8. Any immunosuppressant medication (besides corticosteroids, MMF, or CNIs) within the past 28 days prior to start of the Lead-in Period.
    9. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males
    10. Screening sitting blood pressure (BP) =155 mm Hg (systolic) or =95 mm Hg (diastolic), following at least 5 minutes of sitting rest.
    11. Active/serious infection (including, but not limited to Hepatitis B or C, human immunodeficiency virus (HIV)
    12. History of bilateral vesicoureteral reflux
    13. History of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors, testosterone/anabolic steroids, anthracycline (doxorubicin), heroin
    14. Pregnant female subjects; breastfeeding female subjects; lactating female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 1 highly effective method of contraception
    15. Positive urine drug test
    16. Participation in other studies involving investigational drug or participation in study investigating PF-06730512

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