NCT05016323已完成2 期
A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary 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
- 316
- 试验地点
- 1
- 主要终点
- Change from baseline in urine protein creatinine ratio (UPCR)
研究概览
简要总结
This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.
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
- •Female or male patients ≥18 years old；
- •Biopsy-confirmed primary IgA nephropathy；
- •Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
- •Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
- •Willing and able to take adequate contraception during the trial;
- •Willing and able to give informed consent and follow the protocols during the trial.
排除标准
- •Systemic diseases which could lead to secondary IgA nephropathy；
- •Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
- •Patients with severe cardiovascular diseases；
- •Patients diagnosed with malignancy within the past 5 years；
- •Patients with liver cirrhosis；
- •Patients received organ transplantation；
- •Patients with uncontrolled Type 1 or 2 diabetes；
- •Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
- •Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening；
- •Patients treated with any systemic corticosteroids within the past 3 months before screening.
研究组 & 干预措施
HR19042 Capsules
Experimental
干预措施: HR19042 Capsules (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in urine protein creatinine ratio (UPCR)
时间窗: 9 months
次要结局
- Change from baseline in 24-hour proteinuria(9 months)
- Change from baseline in urine albumin creatinine ratio (UACR)(9 months)
- Change from baseline in estimated GFR(12 months)
- Change from baseline in estimated GFR(9 months)
研究者
研究点 (1)
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