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A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

The primary objectives of this trial are as follows:

- to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo

- to compare the safety profile of patients treated with fresolimumab versus placebo

The secondary objectives are as follows:

- To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo

- To evaluate fresolimumab dose-dependent reduction in proteinuria

- To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in patients treated with fresolimumab versus placebo

- To evaluate the multiple-dose pharmacokinetics of fresolimumab

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: fresolimumab
  • drug: fresolimumab
  • drug: Placebo

Eligibility


Inclusion Criteria:

   - The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental
   Glomerulosclerosis (FSGS) including all histological subtypes.

   - The patient has an eGFR ≥ 30 mL/min/1.73 m2

   - The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg creatinine

   - In the opinion of the Investigator, the patient has steroid-resistant FSGS. The
   patient must have been treated for FSGS with a course of high-dose steroid therapy for
   a minimum of 4 weeks

   - The patient has been treated with an ACEi (angiotensin converting enzyme inhibitor)
   and/or ARB (angiotensin receptor blocker) at a stable dose for a minimum of 4 weeks
   prior to Visit 2 (treatment start)

Exclusion Criteria:

   - The patient has FSGS which in the Investigator's opinion is secondary to another
   condition

   - The patient has been taking prednisone at a dose > 10 mg/day (or equivalent dose of an
   alternative glucocorticoid) within 4 weeks prior to Visit 1 (Screening Visit).

   - The patient has received any other systemically administered immunosuppressive drugs
   (other than glucocorticoids) within 8 weeks prior to Visit 1.

   - The patient has received rituximab within 6 months prior to Visit 1.

   - The patient has a history of organ transplantation.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting