NCT02251067已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients With Nephropathy Due to Diabetes
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
- 165
- 主要终点
- Change from baseline in albuminuria
研究概览
简要总结
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics
- •HbA1c of 7.5-10.5%
- •eGFR 30-110 mL/min/1.73m2
- •stable ACEi/ARB dose regimen
- •stable blood pressure
- •BMI less than or equal to 45 kg/m2
排除标准
- •non-diabetic renal disease
- •history of solid organ or islet cell transplant
- •history of malignancy within previous 5 years
- •systemic immunosuppression therapy
- •clinically significant liver disease, hepatitis B or C or HIV
- •monoclonal antibody treatment within previous year
- •recent acute renal injury or major surgery
- •significant, recent body weight change
- •biopsy proven glomerular disease
研究组 & 干预措施
Placebo
Placebo Comparator
6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
干预措施: Placebo to match VPI-2690B (Drug)
VPI-2690B low dose
Active Comparator
6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
干预措施: VPI-2690B low dose (Drug)
VPI-2690B medium dose
Active Comparator
18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
干预措施: VPI-2690B medium dose (Drug)
VPI-2690B high dose
Active Comparator
48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
干预措施: VPI-2690B high dose (Drug)
结局指标
主要结局
Change from baseline in albuminuria
时间窗: 50 weeks
次要结局
- Change from baseline in eGFR(50 weeks)
研究者
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