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
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.