EUCTR2012-002365-35-DE进行中（未招募）不适用
A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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