NCT02112838已完成2 期
A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 20
- 主要终点
- Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24
研究概览
简要总结
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal biopsy findings consistent with IgA nephropathy
- •Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
- •Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit
- •Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents
排除标准
- •Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
- •Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
研究组 & 干预措施
Fostamatinib 150 mg
Active Comparator
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
干预措施: Fostamatinib 150 mg (Drug)
Fostamatinib 100 mg
Active Comparator
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
干预措施: Fostamatinib 100 mg (Drug)
Placebo
Placebo Comparator
Placebo tablet twice daily by mouth, over the course of 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24
时间窗: Baseline to 24 weeks
Mean change from Baseline (Visit 2) of proteinuria as measured by the spot Protein-Creatinine Ratio (sPCR) at 24 weeks (Visit 9) for the ITT Population
次要结局
- Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies.(Baseline to Week 24)
- Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies.(Baseline to Week 24)
- Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies.(Baseline to Week 24)
- Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9).(Baseline to Week 24)
- Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9).(Baseline to Week 24)
- Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies.(Baseline to Week 24)
- Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies.(Baseline to Week 24)
- Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7).(Baseline to Week 12)
- Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7).(Baseline to Week 12)
- Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7).(Baseline to Week 12)
- Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9).(Baseline to Week 24)
- Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies.(Baseline to Week 24)
- Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7).(Baseline to Week 12)
- Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9).(Baseline to Week 24)
研究者
研究点 (20)
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