NCT06687174尚未招募2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
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
- 入组人数
- 72
- 主要终点
- The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.
研究概览
简要总结
Efficacy and safety of MY008211A in IgAN patients
详细描述
This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.
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)
盲法说明
The trial was a double-blind design.
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
- •Males or females ≥ 18 and ≤ 75 years of age at Screening.
- •Estimated GFR(eGFR) ≥30 mL/min/1.73m
- •Subjects with a biopsy-confirmed diagnosis of IgAN.
- •Urine protein ≥0.75 g/24h from a 24h urine collection.
- •All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
- •Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
- •Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
- •Vaccination for the prevention of S. pneumoniae is required within 5 years.
排除标准
- •Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
- •Presence of any secondary IgAN.
- •Presence of rapidly progressive glomerulonephritis.
- •Presence of other chronic kidney diseases.
- •Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
- •A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
- •Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
- •Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
- •Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
- •Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
- •Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.
研究组 & 干预措施
MY008211A 200 mg BID
Experimental
200 mg taken twice a day.
干预措施: MY008211A tablets (Drug)
MY008211A 400 mg BID
Experimental
400 mg taken twice a day.
干预措施: MY008211A tablets (Drug)
Placebo
Placebo Comparator
Matching placebo to MY008211A taken twice a day.
干预措施: MY008211A tablets matched placebo (Drug)
结局指标
主要结局
The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.
时间窗: Week 12
Participants collected their urine over a 24-hour period.
次要结局
- The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.(up to 24 weeks)
- The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.(up to 24 weeks)
- The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.(up to 24 weeks)
- The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.(up to 24 weeks)
- Change from baseline in serum creatinine at each visit during treatment period.(up to 24 weeks)
- Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period.(up to 24 weeks)
研究者
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