NCT07555054尚未招募2 期
A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2026年5月21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
- 尚未招募
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
研究概览
简要总结
The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-70 years old;
- •Body mass index (BMI) ≥18.0 and <50.0 kg/m^2 at screening;
- •Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;
- •Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m^2 calculated using the 2021 CKD-EPI creatine formula at screening;
- •Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
- •Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
- •Agree to contraception.
排除标准
- •A known or suspected allergy to the investigational medical drug or its components or excipients;
- •Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
- •If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
- •Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
- •Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
- •Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
- •Acute kidney injury or dialysis treatment within 6 months before screening;
- •Received kidney transplant, or plan to receive kidney transplant during the trial;
- •Platelet< 100×10^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
- •Elevations of transaminases (ALT and/or AST) >3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;
- •Serum potassium >5.5 mmol/L at screening.
研究组 & 干预措施
HS-10390 Dose B
Experimental
HS-10390 Dose B
干预措施: HS-10390 (Drug)
HS-10390 Dose C
Experimental
HS-10390 Dose C
干预措施: HS-10390 (Drug)
HS-10390 Dose A
Experimental
HS-10390 Dose A
干预措施: HS-10390 (Drug)
Irbesartan
Active Comparator
Irbesartan will be administered daily as a 150-mg oral tablet. Irbesartan will be administered daily as a 150-mg orally for the first 2 weeks of the study following randomization. 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 in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
时间窗: Frame: From baseline (Day 1) until Week 12 (Day 85)
次要结局
- Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit(From baseline (Day 1) at each visit)
- Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit(From baseline (Day 1) at Each Visit)
- Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12(From baseline (Day 1) until Week 12 (Day 85))
- Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit(From baseline (Day 1) at Each Visit)
- Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit(From baseline (Day 1) at Each Visit)
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(From screening until Follow-up visit (Day 98))
研究者
研究点 (1)
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