NCT02052219撤回3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The proportion of subjects to achieve the proteinuria threshold
研究概览
简要总结
The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older.
- •Biopsy-proven IgA nephropathy
- •Proteinuria ≥ 2g/24hr or equivalent
- •Receiving physician-directed optimized standard of care that includes ACEI and/or ARB.
- •Estimated glomerular filtration rate (eGFR) >40mL/min/1.73m2
排除标准
- •Clinical or histologic evidence of non-IgA-related glomerulonephritis
- •IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
- •Meets eGFR criteria
- •Malignancy within past 5 years
- •Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
- •Liver disease
- •Neutropenia
- •Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
- •History of active tuberculosis or a history of tuberculosis infection
- •Pregnant or nursing
研究组 & 干预措施
Blisibimod
Experimental
干预措施: Blisibimod (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of subjects to achieve the proteinuria threshold
时间窗: Week 24
The proportion of subjects who progress to end-stage renal disease
时间窗: approximately 5 years
次要结局
- Change from baseline in serum creatinine(Week 24)
- Number of Participants with Adverse Events(Week 24)
- The proportion of subjects requiring the addition of corticosteroid or other therapy(Week 24)
- Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets(Week 24)
- Change from baseline in eGFR(Week 24)
研究者
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