Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 主要终点
- 24-hour urinary protein
研究概览
简要总结
This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with IgA nephropathy (IgAN) or IgA vasculitis nephritis (IgAVN) Aged 5 to 18 years Weight ≥25 kg Moderate or heavy proteinuria At enrollment, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m² calculated using the Schwartz formula (36.5 × height [cm] / serum creatinine [μmol/L]).
- •Willing to sign the informed consent form
排除标准
- •There is an ongoing infection that requires antiviral drugs or antibiotics for treatment.
- •The patient has received other B cell-targeting biologics within the three months prior to enrollment.
- •Patients with uncontrolled severe hypertension or diabetes. Individuals with other autoimmune diseases, primary immunodeficiencies, or tumors.
- •A history of organ transplantation. Patients with chronic active infections, such as Epstein-Barr virus, cytomegalovirus, or Mycobacterium tuberculosis, whose disease state may be exacerbated by the use of steroids and immunosuppressive agents.
- •Patients with severe liver failure, heart failure, or end-stage renal disease (ESRD).
- •Any other medical conditions that may place the patient at increased risk by participating in this study.
- •Individuals deemed by the investigator as unsuitable for participation in this study.
研究组 & 干预措施
Experimental group
The intervention measure for the experimental group is the administration of Telitacicept in addition to standard treatment
干预措施: Telitacicept (Drug)
结局指标
主要结局
24-hour urinary protein
时间窗: At each follow-up visit(0、4、8、12、16、20、24week)
次要结局
未报告次要终点
研究者
Guixia Ding
Chief Physician
Nanjing Children's Hospital