A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic/Pharmacodynamic Characteristics of RG002C0106 Injection in Subjects With Primary IgA Nephropathy
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The percentage change from baseline in the mean 24hUPCR)at Week 24 after the first subcutaneous admini;
概览
简要总结
This study looks at how well and safely RG002C0106 works for patients with certain kidney disease: primary IgA nephropathy. It's a phase IIa trial done at several locations where both patients and doctors unknow what treatment is being given.
详细描述
This is a Phase IIa, multicenter, double-blind clinical trial designed to evaluate the efficacy and safety of RG002C0106 in patients with primary IgA nephropathy. The primary objective is to assess the efficacy of RG002C0106 in reducing urinary protein excretion and preserving renal function in these patients. Secondary objectives include characterization of the safety profile, pharmacokinetics, and pharmacodynamics of the treatment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the clinical trial and sign the informed consent form (ICF);
- •Male or female participants aged 18 to 65 years (inclusive) at the time of signing the ICF;
- •Body weight ≥ 40 kg;
- •Negative blood pregnancy test result at screening for female participants of childbearing potential;
- •Renal biopsy pathology results within 10 years prior to screening confirming a diagnosis of primary IgA nephropathy;
- •24-hour urinary protein ≥ 0.75 g/24 h during the screening period;
- •Estimated glomerular filtration rate (eGFR) (calculated using the creatinine-based CKD-EPI formula) ≥ 30 mL/min/1.73 m² during the screening period;
- •Must have received vaccination against Neisseria meningitidis (serogroups A, C, W, Y) and Streptococcus pneumoniae infections at least 2 weeks prior to the first dose of the investigational product and provide proof of such vaccination;
- •Participants must agree and require their partners to use adequate contraception from the time of signing the ICF, throughout the study, and for at least 3 months after the study ends . Male participants must not donate sperm for at least 6 months after the last dose of the investigational product.
排除标准
- •Patients with secondary IgA nephropathy ;
- •Renal biopsy pathology shows renal tubular atrophy or interstitial fibrosis ≥ 50%; or crescent formation in ≥ 50% of glomeruli ;
- •Acute kidney injury or rapidly progressive glomerulonephritis within 4 weeks prior to screening ;
- •Patients with nephrotic syndrome, defined as: 24-hour urinary protein (24h-UP) \>3.5 g with hypoalbuminemia (serum albumin \<3.0 g/dL), hypercholesterolemia (total cholesterol \>350 mg/dL), and edema;
- •Any of the following abnormal laboratory results at screening:
- •Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN);
- •Total bilirubin (TB) \> 1.5 × ULN. However, for patients with a confirmed diagnosis of Gilbert's syndrome, if TB \> 1.5 × ULN but conjugated bilirubin \< ULN, they may be enrolled;
- •Positive test results at screening for HBsAg, HCV Ab,HIV-IgG, or TP-Ab;
- •Poorly controlled type 1 or type 2 diabetes during the screening period ;
- •Persistent clinically significant elevated blood pressure during the screening period ;
研究组 & 干预措施
Experimental: RG002C0106
Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration
干预措施: RG002C0106 (Drug)
Placebo Comparator: placebo
Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration
干预措施: placebo subcutaneous administration (Drug)
结局指标
主要结局
The percentage change from baseline in the mean 24hUPCR)at Week 24 after the first subcutaneous admini;
时间窗: up to 169 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
时间窗: up to 169 days
次要结局
未报告次要终点