NCT00782561终止1 期
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- FibroGen
- 入组人数
- 2
- 主要终点
- Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
- •Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
- •Age less than or equal to 2 years old at onset of proteinuria
- •First morning urine protein/creatinine ratio (U p/c) >1 gm/gm
- •Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2
排除标准
- •Non-FSGS renal disease other than benign cyst; or secondary FSGS
- •History of organ transplantation
- •History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
- •History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
- •Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal
- •Hematocrit < 30%
研究组 & 干预措施
FG-3019
Experimental
FG-3019 5 mg/kg
干预措施: FG-3019 (Drug)
结局指标
主要结局
Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications
时间窗: 32 weeks
次要结局
- Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids(8 weeks)
- Standard plasma and urinary PK parameters(32 weeks)
研究者
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