A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis

Genzyme Corporation0 个研究点目标入组 125 人开始时间: 2013年3月20日最近更新: 2015年10月12日

研究概览

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•Ages Eligible for Study: 18 Years and older
•Genders Eligible for Study: Both
•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 and/or ARB at a stable dose for a minimum of 4 weeks prior to Visit 2 (treatment start)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•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.

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