NCT01665391已完成2 期
A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis
Genzyme, a Sanofi Company32 个研究点 分布在 5 个国家目标入组 36 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 32
- 主要终点
- Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
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
- •The patient has received rituximab within 6 months prior to Visit
- •The patient has a history of organ transplantation.
研究组 & 干预措施
fresolimumab 1 mg/kg total body weight
Experimental
干预措施: fresolimumab (Drug)
fresolimumab 4 mg/kg total body weight
Experimental
干预措施: fresolimumab (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs)
时间窗: Up to Day 112
Percentage of patients achieving partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio)
时间窗: Up to Day 112
次要结局
- Percentage of patients achieving CR in Up/c ratio(Up to Day 112)
- Percentage of patients achieving PR in Up/c ratio(Up to Day 112)
- Change from baseline in eGFR (estimated glomerular filtration rate)(Up to Day 112)
- Change from baseline in Up/c ratio and urinary protein excretion rate(Up to Day 112)
- Time to first PR or CR(Up to Day 112)
- Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate)(Up to Day 112)
- Mean Fresolimumab serum concentration at each sample collection time point(Up to Day 252)
研究者
研究点 (32)
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