NCT05847920终止2 期
A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2023年6月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary 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
- •Able and willing to provide a written informed consent
- •Renal biopsy confirmed primary IgA nephropathy
- •24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
- •eGFR≥30 mL/min/ 1.73m2
- •40kg≤ Weight ≤100kg
- •Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).
排除标准
- •systemic disease which may cause secondary IgA deposition in the mesangial region
- •Specific type of IgA nephropathy
- •History of severe opportunistic infection
- •A history of chronic or recurrent infection within 1 year prior to screening
- •History of active digestive system within one year
- •Have a malignant tumor or a history of malignant tumor
- •Subjects who have received organ transplants
- •Associated with other serious or poorly controlled systemic diseases
- •Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
- •Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
- •Received any systemic glucocorticoid 8 weeks before screening or during run-in period
研究组 & 干预措施
SHR-2010 Injection
Experimental
干预措施: SHR-2010 Injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
时间窗: 12 weeks
Part 2: change from baseline in UPCR at 24weeks.
时间窗: 24 weeks
次要结局
- change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.(12, 24 weeks)
- change from baseline in 24 hours urinary protein at 12 weeks (part 1)(12 weeks)
- change from baseline in 24 hours urinary protein at 24 weeks (part 2)(24 weeks)
- change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.(24 weeks)
- change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.(24, 36 weeks)
- change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）(12 weeks)
研究者
研究点 (1)
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