NCT06635772尚未招募2 期
A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy
Hansoh BioMedical R&D Company0 个研究点目标入组 90 人开始时间: 2024年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Change from baseline in 24-hour urine protein at Week 12
研究概览
简要总结
This study will evaluate the efficacy and safety of HS-10390 in subjects with 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between 18 and 65 years age.
- •Biopsy-proven primary IgA nephropathy.
- •Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
- •Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
- •Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m^2 at screening.
- •Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.
排除标准
- •IgA nephropathy secondary to another condition
- •IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
- •Chronic kidney disease (CKD) in addition to IgAN
- •Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
- •Require any prohibited medications prior to randomizing;
- •Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
- •History of organ transplantation, with exception of corneal transplants
- •Platelet< 100×109/L or hemoglobin value < 90 g/L) or Hematocrit value < 27% (0.27 V/V) at Screening
- •Elevations of transaminases (ALT and/or AST) >2 times upper limit of normal or total bilirubin and/or direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening
- •Potassium >5.5 mmol/L at Screening
研究组 & 干预措施
HS-10390; high dose
Experimental
HS-10390; high dose
干预措施: HS-10390 (Drug)
HS-10390; low dose
Experimental
HS-10390; low dose
干预措施: HS-10390 (Drug)
irbesartan
Active Comparator
Irbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg
干预措施: Irbesartan (Drug)
结局指标
主要结局
Change from baseline in 24-hour urine protein at Week 12
时间窗: up to week 12
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
次要结局
- Change from baseline in 24-hour urine protein (UPCR)(up to Week 12)
- Change from baseline in 24-hour urine protein(UACR)(up to Week 12)
- Change from baseline in 24-hour urine protein(up to Week 12)
- Proportion Change from baseline in 24-hour urine protein(up to Week 12)
- change from baseline in Estimated Glomerular Filtration Rate(up to Week 12)
- Number of subjects with adverse events (AEs)(up to Week 12)
- Plasma Concentration of HS-10390(up to Week 12)
研究者
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