NCT07390123招募中3 期
A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 370
- 试验地点
- 9
- 主要终点
- Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks
研究概览
简要总结
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
- •Female and male patients above 18 years of age.
- •Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m
- •BMI = Body weight (kg) / [Height (m)]2
- •Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
- •24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
- •Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed in two years.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
- •All transplanted patients (any organ, including bone marrow).
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- •Pregnant or nursing (lactating) women.
- •Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
HSK39297 200mgQD
Experimental
干预措施: HSK39297 (Drug)
结局指标
主要结局
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks
时间窗: From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 48 weeks
时间窗: From week 1 to week 48
次要结局
- Annualized total estimated Glomerular Filtration Rate slope over 36 weeks(From week 1 to week 36)
- Annualized total estimated Glomerular Filtration Rate slope over 104 weeks(From week 1 to week 104)
- Incidence , severity and relationship of adverse events during the study period(From week 1 to week 108)
研究者
研究点 (9)
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