NCT06670352已完成2 期
A Randomized, Double-blind, and Placebo-controlled Parallel Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN
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
- 87
- 试验地点
- 2
- 主要终点
- The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment
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 five years.
- •Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
- •Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.
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), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •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 50mg BID
Experimental
干预措施: HSK39297 50mgBID (Drug)
HSK39297 100mg BID
Experimental
干预措施: HSK39297 100mgBID (Drug)
HSK39297 200mg QD
Experimental
干预措施: HSK39297 200mgQD (Drug)
结局指标
主要结局
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment
时间窗: From week 1 to week 12
次要结局
- The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 24 weeks of treatment(From week 1 to week 24)
- The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- The ratio of 24-hour urine protein (24h-UPE) compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- The change in estimated glomerular filtration rate (eGFR, CKD-EPI 2021 formula) compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- The change in blood creatinine compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- The ratio of FMV UPCR, urinary albumin to creatinine ratio (UACR) compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- Incidence , severity and relationship of adverse events during the study period(From week 1 to week 24)
- Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297(From week 1 to week 24)
- Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297(From week 1 to week 24)
- Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297(From week 1 to week 24)
- Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297(From week 1 to week 24)
- Changes in alternative pathway (AP) complement activity compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
- Changes in plasma and urine sC5b-9 levels compared to baseline at each clinical visit point during the treatment period(From week 1 to week 24)
研究者
研究点 (2)
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