NCT06221059已完成2 期
A Phase II Clinical Study of Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in the Treatment of Patients With Chronic Kidney Disease (Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Design)
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2024年3月2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
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 13 in UACR
研究概览
简要总结
The objective of this study was to evaluate the efficacy of HRS-1780 tablets or Henagliflozin Proline tablets in patients with chronic kidney disease by evaluating UACR change from baseline to Week 13
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-75 years old
- •Body mass index (BMI) ≥18.0 and <50.0 kg/m2 at the screening visit
- •Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks 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 m2 calculated using the CKD-EPI formula at the screening visit
- •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 the screening visit
- •HbA1c <9.0% at the screening visit
排除标准
- •A known or suspected allergy to the investigational drug or its components or excipients;
- •Receive a potent inhibitor/inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to screening;
- •Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs, endothelin receptor antagonists;
- •Receive SGLT-2 or SGLT-1/2 inhibitors within 4 weeks before screening
- •Received glucagon-like peptide-1 receptor agonist (GLP-1RA) within 8 weeks before screening
- •Received systemic glucocorticoid therapy within 3 months before screening
- •Received immunosuppressive drugs or biological agents
- •Received any other study drug treatment within 3 months or 5 half-lives prior to screening
- •Severe hypertension that was not controlled at screening visit or random visit (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), or systolic blood pressure <90 mmHg
- •Have urinary tract infection or/and genital infection at the screening visit or random visit, or have a history of repeated urinary tract infection or/and genital infection
- •Diagnosed or suspected 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
研究组 & 干预措施
HRS-1780 dose 1
Experimental
干预措施: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo (Drug)
HRS-1780 dose 2
Experimental
干预措施: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo (Drug)
Henagliflozin Proline
Active Comparator
干预措施: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo (Drug)
Placebo
Placebo Comparator
干预措施: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 13 in UACR
时间窗: From Baseline to Week 13
次要结局
- Change From Baseline to Week 13 in UACR category （>20%, >30%, >40%)(From Baseline to Week 13)
- Change From Baseline to Week 13 in 24-hour urinary protein quantification(From Baseline to Week 13)
- Change From Baseline to Week 4, Week 7 in UACR(From Baseline to Week 4, Week 7)
- Change From Baseline to Week 13 in blood pressure(From Baseline to Week 13)
- Change From Baseline to Week 13 in estimated glomerular filtration rate (eGFR). An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.(From Baseline to Week 13)
研究者
研究点 (1)
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